FDA approved drugs by year
2014-2008 FDA approved drugs list[edit | edit source]
The US Food and Drug Administration approved Hetlioz ( Tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder “non-24”) in totally blind individuals. Non-24 is a chronic circadian rhythm ( Body clock) disorder in the blind that causes problems with the timing of sleep. This is the first fda approval of a treatment for the disorder.
The US Food and Drug Administration approved Mekinist ( Trametinib) in combination with Tafinlar ( Dabrafenib) to treat patients with advanced melanoma that is unresectable Cannot be removed by surgery) or metastatic Late-stage).
The US Food and Drug Administration approved the first gel sealant for use in stopping fluid from leaking through the incision in a patient’s cornea after cataract surgery with intraocular lens placement in adults.
The US Food and Drug Administration approved Farxiga ( Dapagliflozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
On feb. 24, 2014, the US Food and Drug Administration approved Myalept Metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy
The US Food and Drug Administration approved Northera capsules ( Droxidopa) for the treatment of Neurogenic orthostatic hypotension ( Noh).
The US Food and Drug Administration approved Vimizim ( Elosulfase alfa), the first fda-approved Treatment for Mucopolysaccharidosis type iva Morquio a syndrome).
The US Food and Drug Administration expanded the approved Use of imbruvica ( Ibrutinib) for chronic lymphocytic leukemia Cll) patients who have received at least one previous therapy.
The US Food and Drug Administration approved the expanded use of the dexcom g4 platinum continuous monitoring system for patients with diabetes ages 2 to 17 years.
- Alprolix, coagulation factor ix ( Recombinant), fc fusion protein
The US Food and Drug Administration approved Alprolix, coagulation factor ix ( Recombinant), fc fusion protein, for use in adults and children who have hemophilia b.
The US Food and Drug Administration approved Topamax ( Topiramate) for prevention ( Prophylaxis) of migraine headaches in adolescents ages 12 to 17.
The US Food and Drug Administration approved Otezla ( Apremilast) to treat adults with active psoriatic arthritis ( Psa).
The US Food and Drug Administration approved Impavido ( Miltefosine) to treat a tropical disease called leishmaniasis.
The US Food and Drug Administration granted accelerated approval to zykadia ( Ceritinib) for patients with a certain type of late-stage ( Metastatic) non-small cell lung cancer Nsclc)
The US Food and Drug Administration approved Sylvant ( Siltuximab) to treat patients with multicentric castleman’s disease ( Mcd), a rare disorder similar to lymphoma Cancer of the lymph nodes).
The US Food and Drug Administration approved Cyramza ( Ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.
The US Food and Drug Administration approved Ragwitek, the first allergen extract administered under the tongue ( Sublingually) to treat short ragweed pollen induced allergic rhinitis ( Hay fever), with or without conjunctivitis Eye inflammation), in adults 18 years through 65 years of age.
The US Food and Drug Administration approved Tanzeum ( Albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
The US Food and Drug Administration approved A prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio Naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet
The US Food and Drug Administration recently approved Oralair to treat allergic rhinitis ( Hay fever) with or without conjunctivitis Eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual Under the tongue) allergen extract approved In the united states. After administration of the first dose at the health care provider’s office, where the patient can be observed for potential adverse reactions, oralair can be taken at home.
The US Food and Drug Administration approved Zontivity ( Vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.
The US Food and Drug Administration approved Entyvio ( Vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe crohn‘s disease.
The US Food and Drug Administration approved Dalvance ( Dalbavancin), a new antibacterial drug used to treat adults with skin infections.
The US Food and Drug Administration approved the first generic versions of celebrex ( Celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term ( Acute) pain, and other conditions.
- Afrezza Insulin human) inhalation powder
The US Food and Drug Administration approved Afrezza Insulin human) inhalation powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal
The US Food and Drug Administration approved Sivextro ( Tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections. Sivextro is approved To treat patients with acute bacterial skin and skin structure infections Absssi) caused by certain susceptible bacteria, including staphylococcus aureus Including methicillin-resistant strains ( Mrsa) and methicillin-susceptible strains), various streptococcus species, and enterococcus faecalis. Sivextro is available for intravenous and oral use.
The US Food and Drug Administration approved Eloctate, antihemophilic factor ( Recombinant), fc fusion protein, for use in adults and children who have hemophilia a. Eloctate is the first hemophilia a treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.
The US Food and Drug Administration approved Striverdi respimat ( Olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease ( Copd), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction. Striverdi respimat can be used once daily over a long period of time
- Targiniq er Oxycodone hydrochloride and naloxone hydrochloride extended-release tablets)
The US Food and Drug Administration approved Targiniq er Oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting Er/la) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq er is the second er/la opioid analgesic with fda-approved Labeling describing the product’s abuse-deterrent properties consistentwith the fda’s 2013 draft guidance for industry,
The US Food and Drug Administration approved Zydelig ( Idelalisib) to treat patients with three types of blood cancers.
- Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia Cll) has returned ( Relapsed). Used in combination with rituxan ( Rituximab), zydelig is to be used in patients for whom rituxan alone would be considered appropriate therapy due to other existing medical conditions ( Co-morbidities).Zydelig is the fifth new drug with breakthrough therapy designation to be approved By the fda and the third drug with this designation approved To treat cll.
- Ruconest
The US Food and Drug Administration yesterday approved Ruconest, the first recombinant c1-esterase inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema ( Hae).
The US Food and Drug Administration approved Beleodaq ( Belinostat) for the treatment of patients with peripheral t-cell lymphoma ( Ptcl), a rare and fast-growing type of non-hodgkin lymphoma ( Nhl). The action was taken under the agency’s accelerated approval program.
The US Food and Drug Administration approved Jardiance ( Empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes.
- Jardiance is a sodium glucose co-transporter 2 Sglt2) inhibitor. It works by blocking the reabsorption of glucose ( Blood sugar) by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels. The drug’s safety and effectiveness were evaluated in seven clinical trials with 4,480 patients with type 2 diabetes receiving jardiance. The pivotal trials showed that jardiance improved hemoglobin a1c levels A measure of blood sugar control) compared to placebo.
- Oritavancin
The US Food and Drug Administration approved Orbactiv ( Oritavancin), a new antibacterial drug to treat adults with skin infections. Orbactiv is approved To treat patients with acute bacterial skin and skin structure infections Absssi) caused by certain susceptible bacteria, including staphylococcus aureus Including methicillin-susceptible and methicillin-resistant strains), various streptococcus species and enterococcus faecalis. Orbactiv is administered intravenously.
The US Food and Drug Administration approved Belsomra ( Suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep ( Insomnia). Belsomra is an orexin receptor antagonist and is the first approved Drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signaling ( Action) of orexin in the brain.
The US Food and Drug Administration approved Cerdelga ( Eliglustat) for the long-term treatment of adult patients with the type 1 form of gaucher disease, a rare genetic disorder. Cerdelga is a hard gelatin capsule containing eliglustat that is taken orally. In patients with gaucher disease type 1, the drug slows down the production of the fatty materials by inhibiting the metabolic process that forms them. Type 1 gaucher disease is estimated to affect about 6,000 people in the united states.
The US Food and Drug Administration granted accelerated approval to keytruda ( Pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.
- Keytruda is the first approved Drug that blocks a cellular pathway known as pd-1, which restricts the body’s immune system from attacking melanoma cells. Keytruda is intended for use following treatment with ipilimumab, a type of immunotherapy. For melanoma patients whose tumors express a gene mutation called braf v600, keytruda is intended for use after treatment with ipilimumab and a braf inhibitor, a therapy that blocks activity of braf gene mutations.
- Naloxegol
The US Food and Drug Administration approved Movantik ( Naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain. Movantik’s safety and effectiveness were established in two clinical trials of 1,352 participants who had taken opioids for at least four weeks for non-cancer related pain and had opioid-induced constipation. Participants were randomly assigned to receive 12.5 mg or 25 mg of movantik or placebo ( Sugar pill) once daily for 12 weeks. The trials were designed to measure the change in the number of bowel movements per week from the start of the study.
The US Food and Drug Administration approved Trulicity ( Dulaglutide), a once-weekly subcutaneous injection to improve glycemic control ( Blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.
- Trulicity is a glucagon-like peptide-1 Glp-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in six clinical trials in which 3,342 patients with type 2 diabetes received trulicity. Patients receiving trulicity had an improvement in their blood sugar control as observed with reductions in hba1c level Hemoglobin a1c is a measure of blood sugar control).
- Ledipasvir and sofosbuvir
The US Food and Drug Administration approved Harvoni ( Ledipasvir and sofosbuvir) to treat chronic hepatitis c virus Hcv) genotype 1 infection. Harvoni is the first combination pill approved To treat chronic hcv genotype 1 infection. It is also the first approved Regimen that does not require administration with interferon or ribavirin, two fda-approved Drugs also used to treat hcv infection.
The US Food and Drug Administration approved Akynzeo Netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo is a fixed combination capsule comprised of two drugs. Oral palonosetron, approved In 2008, prevents nausea and vomiting during the acute phase Within the first 24 hours) after the start of cancer chemotherapy. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase From 25 to 120 hours) after the start of cancer chemotherapy.
The US Food and Drug Administration approved Lumason Sulfur hexafluoride lipid microsphere) for patients whose ultrasound image of the heart Echocardiograms) are hard to see with ultrasound waves.
- Lumason is a contrast agent made up of gas-filled microbubbles Or microspheres) that reflect the sound waves to enhance the image. Lumason helps a physician see a patient's heart more clearly, allowing for clearer imaging of the left ventricle chamber and the smooth edge on the inside of the chambers of the heart, known as the endocardium.
- Nintedanib
The US Food and Drug Administration approved Ofev ( Nintedanib) for the treatment of idiopathic pulmonary fibrosis ( Ipf). Ofev is a kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue. Its safety and effectiveness were established in three clinical trials of 1,231 patients with ipf. The decline in forced vital capacity – the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible – was significantly reduced in patients receiving ofev compared to patients receiving placebo.
The US Food and Drug Administration approved Esbriet ( Pirfenidone) for the treatment of idiopathic pulmonary fibrosis ( Ipf). Esbriet acts on multiple pathways that may be involved in the scarring of lung tissue. Its safety and effectiveness were established in three clinical trials of 1,247 patients with ipf. The decline in forced vital capacity – the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible – was significantly reduced in patients receiving esbriet compared to patients receiving placebo.
The US Food and Drug Administration approved Blincyto ( Blinatumomab) to treat patients with philadelphia chromosome-negative precursor b-cell acute lymphoblastic leukemia B-cell all), an uncommon form of all. Blincyto is an example of immunotherapy, a treatment that uses certain parts of a person’s immune system to fight diseases such as cancer. Blincyto is the first approved Drug that engages the body’s t-cells, a type of white blood cell or lymphocyte, to destroy leukemia cells. The drug acts as a connector between a protein called cd19, which is found on the surface of most b-cell lymphoblasts, and cd3, a protein on t-cell lymphocytes. It is intended for patients whose cancer returned after treatment ( Relapsed) or did not respond to previous treatment ( Refractory).
The US Food and Drug Administration approved Xtoro Finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear. Xtoro is an eardrop approved To treat acute otitis externa caused by pseudomonas aeruginosa and staphylococcus aureus. Xtoro is the newest drug belonging to the fluoroquinolone antimicrobial drug class to be approved By the fda. It joins several other antibacterial drug products previously approved To treat ear infections.
The US Food and Drug Administration granted accelerated approval to lynparza ( Olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective brca genes, as detected by an fda-approved Test.
- Lynparza is a poly adp-ribose polymerase ( Parp) inhibitor that blocks enzymes involved in repairing damaged dna. It is intended for women with heavily pretreated ovarian cancer that is associated with defective brca genes.
- Viekira pak Ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets)
The US Food and Drug Administration approved Viekira pak Ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis c virus Hcv) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis. Viekira pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of hcv. It also contains ritonavir, a previously approved Drug, which is used to increase blood levels of paritaprevir. Viekira pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly Decompensated cirrhosis).
The US Food and Drug Administration approved Zerbaxa ( Ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections Ciai) and complicated urinary tract infections Cuti).
- Zerbaxa is a combination product containing ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor. Zerbaxa is used to treat cuti, including kidney infection ( Pyelonephritis). It is used in combination with metronidazole to treat ciai.
- Peramivir
The US Food and Drug Administration approved Rapivab ( Peramivir) to treat influenza infection in adults. Rapivab is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from infected cells. Neuraminidase inhibitors are commonly used to treat flu infection. Rapivab is the first neuraminidase inhibitor approved For intravenous ( Iv) administration and is administered as a single iv dose. It is intended for patients 18 years and older who have acute uncomplicated influenza and have shown symptoms of flu for no more than two days.
The US Food and Drug Administration granted accelerated approval to opdivo ( Nivolumab), a new treatment for patients with unresectable Cannot be removed by surgery) or metastatic Advanced) melanoma who no longer respond to other drugs. Opdivo works by inhibiting the pd-1 protein on cells, which blocks the body’s immune system from attacking melanoma tumors. Opdivo is intended for patients who have been previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation called braf v600, for use after treatment with ipilimumab and a braf inhibitor. 20013 drugs approved By month
Fda approves kineret ( Anakinra) for the treatment of nomid
U.S. Fda approves bayer's skyla Levonorgestrel-releasing intrauterine system) 13.5 mg for prevention of pregnancy for up to three years
Santarus receives fda approval of uceris ( Budesonide) for the induction of remission in patients with active, mild to moderate ulcerative colitis
Fda approves flublok Influenza vaccine, recombinant hemagglutinin) - new seasonal influenza vaccine made using novel technology
Fda approves octaplas Pooled plasma ( Human)) to treat patients with blood clotting disorders
Fda approves botox Onabotulinumtoxina) to treat overactive bladder
Nupathe's zecuity ( Sumatriptan) approved by the fda for the acute treatment of migraine
Fda approves exjade ( Deferasirox) to remove excess iron in patients with genetic blood disorder
Pfizer receives fda approval for the use of prevnar 13 Pneumococcal 13-valent conjugate vaccine)in vaccine-naive children and adolescents aged 6 years through 17 years for the prevention of invasive pneumococcal disease
Fda approves gleevec ( Imatinib mesylate) for children with acute lymphoblastic leukemia
Fda approves over-the-counter oxytrol (oxybutynin) transdermal system ) for women to treat overactive bladder
Takeda receives fda approval for Nesina ( Alogliptin) for type 2 diabetes
Takeda receives fda approval for Oseni Alogliptin and pioglitazone) for type 2 diabetes
Takeda receives fda approval for Kazano Alogliptin and metformin) for type 2 diabetes
Fda approves new orphan drug kynamro ( Mipomersen) to treat inherited cholesterol disorder
Fda approved the first generic version of the cancer drug doxil Doxorubicin hydrochloride liposome injection)
Fda approves stivarga ( Regorafenib) for advanced gastrointestinal stromal tumors
Fda approves osphena ( Ospemifene) for postmenopausal women experiencing pain during sex
Fda approves kadcyla ( Ado-trastuzumab emtansine), new treatment for late-stage breast cancer
Fda approves pomalyst ( Pomalidomide) for advanced multiple myeloma
Fda approves new drug ravicti ( Glycerol phenylbutyrate) for the chronic management of some urea cycle disorders
Fda approves stivarga ( Regorafenib) for advanced gastrointestinal stromal tumors
Fda approves new multiple sclerosis treatment: tecfidera ( Dimethyl fumarate)
Fda approves tobi podhaler Tobramycin inhalation powder) to treat a type of bacterial lung infection in cystic fibrosis patients
Fda approves lymphoseek Technetium tc 99m tilmanocept) to help locate lymph nodes in patients with certain cancers
Fda approves invokana ( Canagliflozin) to treat type 2 diabetes
Fda approves first botulism antitoxin ( Equine) for use in neutralizing all seven known botulinum nerve toxin serotypes
Fda approves dotarem Gadoterate meglumine), a new magnetic resonance imaging agent
Fda approves procysbi ( Cysteamine bitartrate) for rare genetic condition
Fda approves abuse-deterrent labeling for reformulated oxycontin Oxycodone hydrochloride controlled-release)
Fda approves plan b one-step ( Levonorgestrel) emergency contraceptive without a prescription for women 15 years of age and older
Fda approves kcentra Prothrombin complex concentrate, human) for the urgent reversal of anticoagulation in adults with major bleeding
Fda approves diclegis Doxylamine succinate and pyridoxine hydrochloride) for pregnant women experiencing nausea and vomiting
Fda approves nymalize-first nimodipine oral solution for use in certain brain hemorrhage patients
Fda approves breo ellipta to treat chronic obstructive pulmonary disease
Fda approves tafinlar ( Dabrafenib), companion diagnostic test for advanced skin cancer
Fda approves mekinist ( Trametinib), companion diagnostic test for advanced skin cancer
Fda approves simponi ( Golimumab) to treat ulcerative colitis
Fda approves new drug xofigo Radium ra 223 dichloride) for advanced prostate cancer
Fda approved the cobas egfr mutation test, a companion diagnostic for the cancer drug tarceva ( Erlotinib)
Fda approved Brisdelle ( Paroxetine)to treat moderate to severe hot flashes ( Vasomotor symptoms) associated with menopause
Fda approved Rixubis [coagulation factor ix ( Recombinant)] for use in people with hemophilia b who are 16 years of age and older
Fda approved the use of plan b one-step ( Levonorgestrel) as a nonprescription product for all women of child-bearing potential
Fda approved Use of xgeva ( Denosumab) to treat adults and some adolescents with giant cell tumor of the bone Gctb), a rare and usually non-cancerous tumor
Fda approved the antibiotic vibativ ( Telavancin) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia Habp/vabp) caused by staphylococcus aureus
Fda approves gilotrif ( Afatinib) for patients with late stage ( Metastatic) non-small cell lung cancer Nsclc)
The US Food and Drug Administration approved Tivicay ( Dolutegravir), a new drug to treat hiv-1 infection.
The US Food and Drug Administration brintellix ( Vortioxetine) to treat adults with major depressive disorder.
The US Food and Drug Administration expanded the approved Uses of abraxane Paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage ( Metastatic) pancreatic cancer.
The US Food and Drug Administration approved the first generic version of xeloda ( Capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum ( Colorectal cancer) that has spread to other parts of the body ( Metastatic), and metastatic breast cancer.
The US Food and Drug Administration granted accelerated approval to perjeta ( Pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery Neoadjuvant setting)
The US Food and Drug Administration approved Zohydro er Hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.
- Vizamyl Flutemetamol f 18 injection)
The US Food and Drug Administration approved Vizamyl Flutemetamol f 18 injection), a radioactive diagnostic drug for use with positron emission tomography ( Pet) imaging of the brain in adults being evaluated for alzheimer's disease ( Ad) and dementia.
The US Food and Drug Administration approved Opsumit ( Macitentan), a new drug to treat adults with pulmonary arterial hypertension ( Pah), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation.
The US Food and Drug Administration approved Adempas ( Riociguat) to treat adults with two forms of pulmonary hypertension.
The US Food and Drug Administration approved Clinolipid Lipid injectable emulsion, usp) for intravenous feeding ( Parenteral nutrition) in adult patients, providing a source of calories and essential fatty acids for adult patients who are unable to eat or drink. Clinolipid was granted a priority review to help alleviate a drug shortage.
- Olysio ( Simeprevir)
The US Food and Drug Administration approved Olysio ( Simeprevir), a new therapy to treat chronic hepatitis c virus infection.
- Influenza a ( H5n1) virus monovalent vaccine
The US Food and Drug Administration approved the first adjuvanted vaccine for the prevention of h5n1 influenza, commonly known as avian or bird flu. The vaccine, influenza a ( H5n1) virus monovalent vaccine, adjuvanted, is for use in people 18 years of age and older who are at increased risk of exposure to the h5n1 influenza virus.
The US Food and Drug Administration expanded the approved Uses of nexavar ( Sorafenib) to treat late-stage ( Metastatic) differentiated thyroid cancer
The US Food and Drug Administration approved Imbruvica ( Ibrutinib) to treat patients with mantle cell lymphoma Mcl), a rare and aggressive type of blood cancer.
The US Food and Drug Administration approved Aptiom ( Eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
The US Food and Drug Administration approved the first generic versions of aciphex Rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease ( Gerd) in adults and adolescents Ages 12 and up).
The US Food and Drug Administration approved Gazyva ( Obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia Cll).
- Tretten Coagulation factor xiii a-subunit ( Recombinant)
The US Food and Drug Administration approved Tretten, coagulation factor xiii a-subunit ( Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, known as congenital factor xiii a-subunit deficiency.
The US Food and Drug Administration approved Anoro ellipta Umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease ( Copd).
The US Food and Drug Administration approved the first generic versions of cymbalta Duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.
The US Food and Drug Administration approved Sovaldi ( Sofosbuvir) to treat chronic hepatitis c virus Hcv) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of hcv infection without the need for co-administration of interferon.
The US Food and Drug Administration approved A new use for xiaflex ( Collagenase clostridium histolyticum) as the first fda-approved Medicine to treat men with bothersome curvature of the penis, a condition known as peyronie’s disease. Drugs approved In 2012 Brentuximab vedotin Seattle genetics announces updates to adcetris ( Brentuximab vedotin)prescribing information
Fda approves voraxaze ( Glucarpidase) to treat patients with toxic methotrexate levels
U.S. Food and drug administration approves new formulations of viread ( Tenofovir disoproxil fumarate) for use by children living with hiv
Fda approves subcutaneous administration of velcade ( Bortezomib) in all approved indications
Fda approves zetonna ( Ciclesonide) nasal aerosol for allergic rhinitis
New fda approved labeling for vytorin ( Ezetimibe/simvastatin) includes results from the study of heart and renal protection ( Sharp) in patients with moderate to severe chronic kidney disease
Ucb announces fda approval for Keppra ( Levetiracetam) in infants and children from one month of age with partial onset seizures
Fda approves picato ( Ingenol mebutate) gel, the first and only topical actinic keratosis ( Ak) therapy with 2 or 3 consecutive days of once-daily dosing
Fda approves inlyta ( Axitinib) for advanced renal cell carcinoma
Fda approves bydureon ( Exenatide) - the first and only once-weekly treatment for type 2 diabetes
Fda approves erivedge ( Vismodegib) for basal cell carcinoma
Fda approves kalydeco ( Ivacaftor) to treat rare form of cystic fibrosis
Fda approves gleevec ( Imatinib mesylate) for expanded use in patients with rare gastrointestinal cancer
Fda approves jentadueto ( Linagliptin/metformin hydrochloride) for the treatment of adult patients with type 2 diabetes
Fda approves janumet xr Sitagliptin and metformin hcl extended-release) for type 2 diabetes, offering the powerful efficacy of janumet Sitagliptin/metformin hcl) now available with once-daily convenience
Vyvanse ( Lisdexamfetamine dimesylate) capsules, ( Cii) now approved in the us for maintenance treatment in adults with adhd
Sanofi announces fda approval of sklice ( Ivermectin)lotion for the treatment of head lice
Mobius therapeutics receives final fda approval for New glaucoma drug mitosol ( Mitomycin)
Fda approves zioptan Tafluprost ophthalmic solution), merck's once-daily, preservative-free ophthalmic medication
Fda approves korlym ( Mifepristone) for patients with endogenous cushing's syndrome
U.S. Fda approves lower dose formulation of angeliq Drospirenone and estradiol) tablets
Fda approves flumist Influenza virus vaccine, live, intranasal) to prevent seasonal influenza
Aptalis pharma announces fda approval of ultresa ( Pancrelipase) delayed release capsules
Discovery labs announces fda approval of surfaxin ( Lucinactant) for prevention of respiratory distress syndrome
U.S. Fda approves natazia Dienogest and estradiol valerate) first and only oral contraceptive demonstrated to treat heavy menstrual bleeding Hmb)
Fda approves binosto(alendronate), first and only effervescent osteoporosis treatment in a buffered solution
Teva announces fda approval of qnasl ( Beclomethasone dipropionate), a new nonaqueous nasal aerosol, for the treatment of allergic rhinitis
Fda approves intelence ( Etravirine) tablets for treatment-experienced pediatric patients with hiv-1, following priority review
Affymax and takeda announce fda approval of omontys ( Peginesatide) injection for the treatment of anemia due to chronic kidney disease Ckd) in adult patients on dialysis
Fda approves levemir ( Insulin detemir) pregnancy category change for women with diabetes
Neupro ( Rotigotine )approved by u.S. Fda for parkinson's disease and restless legs syndrome
Fda approves amyvid Florbetapir f 18 injection) for use in patients being evaluated for alzheimer's disease and other causes of cognitive decline Liraglutide [rdna] injection Victoza ( Liraglutide) label updated to include data showing superior efficacy when compared to januvia
Novartis drug afinitor ( Everolimus) approved By fda as first medication to treat patients with non-cancerous kidney tumors associated with tsc
Fda approves votrient ( Pazopanib) for advanced soft tissue sarcoma
Fda approves stendra ( Avanafil) for erectile dysfunction
Fda approves levaquin ( Levofloxacin) as an antibacterial treatment for plague
Fda approves new orphan drug elelyso ( Taliglucerase alfa) to treat a form of gaucher disease
Meda announces dymista Azelastine and fluticasone) approved by the fda for allergic rhinitis
Fabior ( Tazarotene) fda approval history for acne
Digestive care, inc. Announces fda approval of pertzye ( Pancrelipase) delayed-release capsules
Fda approves levemir ( Insulin detemir) for expanded use in children two to five years of age with type 1 diabetes
Gsk and xenoport receive fda approval for Horizant for postherpetic neuralgia
Fda approves perjeta ( Pertuzumab) for people with her2-positive metastatic breast cancer
Menhibrix Meningococcal groups c and y and haemophilus b tetanus toxoid conjugate vaccine) fda approval history
Fda approves lyrica ( Pregabalin) for the management of neuropathic pain associated with spinal cord injury based on priority review
Baxter announces fda approval for Gammagard liquid Immune globulin infusion ( Human)) as a treatment for multifocal motor neuropathy
Fda approves belviq ( Lorcaserin) to treat some overweight or obese adults
Fda approves truvada for reducing the risk of sexually acquired hiv infection
- Sodium picosulfate, magnesium oxide and citric acid) for oral solution
Fda approves prepopik Sodium picosulfate, magnesium oxide and citric acid) for oral solution )for colonoscopy prep
Fda approves truvada Emtricitabine and tenofovir) for reducing the risk of sexually acquired hiv infection
Fda approves prepopik(sodium picosulfate, magnesium oxide and citric acid) for oral solution for colonoscopy prep
Fda approves weight-management drug qsymia ( Phentermine and topiramate)
Fda approves kyprolis ( Carfilzomib) for patients with advanced multiple myeloma
Fda approves afinitor ( Everolimus) for advanced breast cancer
Fda approves tudorza ( Aclidinium bromide) pressair to treat chronic obstructive pulmonary disease
Amarin announces fda approval of vascepa ( Icosapent ethyl) capsules for the reduction of triglyceride levels in adult patients with severe hypertriglyceridemia
Horizon pharma announces fda approval of rayos ( Prednisone) delayed-release tablets for rheumatoid arthritis and multiple additional indications
Fda approves zaltrap ( Ziv-aflibercept) for metastatic colorectal cancer
Fda approves marqibo Vincristine sulfate liposomes) for philadelphia chromosome negative acute lymphoblastic leukemia
Fda approves lucentis Ranibizumab injection) for treatment of diabetic macular edema ( Dme)
Sanofi announces fda approval for Auvi-q(epinephrine), first voice-guided epinephrine auto-injector for patients with life-threatening allergies
Fda approves updated prescribing information for tradjenta ( Linagliptin) tablets for add-on therapy to insulin in adults with type 2 diabetes
Reckitt benckiser pharmaceuticals inc. Announces fda approval of two new dosage strengths of suboxone Buprenorphine and naloxone) sublingual film C-iii) for maintenance treatment of opioid dependence
Fda approves mallinckrodt's exalgo Hydromorphone hcl) extended-release tablets 32 mg ( Cii) for opioid-tolerant patients with moderate-to-severe chronic pain
Fda approves new combination pill stribild Cobicistat, elvitegravir, emtricitabine and tenofovir)for hiv treatment
Fda approves nucynta er ( Tapentadol) extended-release oral tablets for the management of neuropathic pain associated with diabetic peripheral neuropathy
Fda approves afinitor disperz ( Everolimus)- first drug formulated for children with rare brain tumor
Fda approves tbo-filgrastim for severe neutropenia in certain cancer patients
Fda approves linzess ( Linaclotide)to treat certain cases of irritable bowel syndrome and constipation
Fda approves xtandi ( Enzalutamide)for late-stage castration-resistant prostate cancer
Higher dose of novartis drug exelon ( Rivastigmine) patch approved by fda for patients with mild to moderate alzheimer's disease
Fda approves bosulif ( Bosutinib)for chronic myelogenous leukemia
Fda approves new multiple sclerosis treatment aubagio ( Teriflunomide)
Fda approves new indication for prolia ( Denosumab) for the treatment of bone loss in men with osteoporosis at high risk for fracture
Fda approves stivarga ( Regorafenib) for advanced colorectal cancer
Fda approves humira ( Adalimumab) to treat ulcerative colitis
Nextwave pharmaceuticals receives fda approval of quillivant xr(methylphenidate) for once-daily treatment of adhd
Sigma-tau pharmaceuticals, inc. Receives fda approval of cystaran Cysteamine ophthalmic solution) 0.44%
Fda approves abraxane Paclitaxel protein-bound) for the first-line treatment of advanced non-small cell lung cancer
Fda approves jetrea ( Ocriplasmin) for symptomatic vitreomacular adhesion in the eyes
Fda approves fycompa ( Perampanel) to treat seizures
Fda approves synribo ( Omacetaxine mepesuccinate) for chronic myelogenous leukemia
Fda expands use of xarelto ( Rivaroxaban) to treat, reduce recurrence of blood clots
Fda approves xeljanz ( Tofacitinib) for rheumatoid arthritis
Fda has approved Promacta Eltrobopag) for the treatment of thrombocytopenia Low blood platelet counts) in patients with chronic hepatitis c
Fda approves flucelvax Influenza virus vaccine) - first seasonal influenza vaccine manufactured using cell culture technology
Fda approves cometriq ( Cabozantinib) to treat rare type of thyroid cancer
Fda has approved Evarrest Fibrin sealant patch), a novel product that rapidly and reliably aids in stopping problematic bleeding during surgery.
Fda expands zytiga’s use for late-stage prostate cancer
Fda approves iclusig ( Ponatinib) to treat two rare types of leukemia
Fda approves raxibacumab to treat inhalational anthrax
Fda approves signifor ( Pasireotide), a new orphan drug for cushing’s disease
Fda approves glaxosmithkline's fluarix quadrivalent Influenza virus vaccine, inactivated) - four-strain seasonal influenza vaccine for use in the u.S.
Fda approves adasuve ( Loxapine) inhalation powder for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults
Fda approves biotest's bivigam, an intravenous immune globulin ( Human), 10% liquid
Fda expands tamiflu's ( Oseltamivir) use to treat children younger than one year
Fda approves gattex(teduglutide) to treat short bowel syndrome
Fda approves varizig Varicella zoster immune globulin) for reducing chickenpox symptoms
Fda approves juxtapid ( Lomitapide) - new orphan drug for rare cholesterol disorder
Fda approves eliquis ( Apixaban) to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation
Fda approves sirturo ( Bedaquiline) to treat multi-drug resistant tuberculosis
Fda approves fulyzaq ( Crofelemer) - first anti-diarrheal drug for hiv/aids patients List of fda approved Drugs 2011 Brentuximab vedotin Seattle genetics announces updates to adcetris ( Brentuximab vedotin)prescribing information
Fda approves voraxaze ( Glucarpidase) to treat patients with toxic methotrexate levels
U.S. Food and drug administration approves new formulations of viread ( Tenofovir disoproxil fumarate) for use by children living with hiv
Fda approves subcutaneous administration of velcade ( Bortezomib) in all approved indications
Fda approves zetonna ( Ciclesonide) nasal aerosol for allergic rhinitis
New fda approved labeling for vytorin ( Ezetimibe/simvastatin) includes results from the study of heart and renal protection ( Sharp) in patients with moderate to severe chronic kidney disease
Ucb announces fda approval for Keppra ( Levetiracetam) in infants and children from one month of age with partial onset seizures
Fda approves picato ( Ingenol mebutate) gel, the first and only topical actinic keratosis ( Ak) therapy with 2 or 3 consecutive days of once-daily dosing
Fda approves inlyta ( Axitinib) for advanced renal cell carcinoma
Fda approves bydureon ( Exenatide) - the first and only once-weekly treatment for type 2 diabetes
Fda approves erivedge ( Vismodegib) for basal cell carcinoma
Fda approves kalydeco ( Ivacaftor) to treat rare form of cystic fibrosis
Fda approves gleevec ( Imatinib mesylate) for expanded use in patients with rare gastrointestinal cancer
Fda approves jentadueto ( Linagliptin/metformin hydrochloride) for the treatment of adult patients with type 2 diabetes
Fda approves janumet xr Sitagliptin and metformin hcl extended-release) for type 2 diabetes, offering the powerful efficacy of janumet Sitagliptin/metformin hcl) now available with once-daily convenience
Vyvanse ( Lisdexamfetamine dimesylate) capsules, ( Cii) now approved in the us for maintenance treatment in adults with adhd
Sanofi announces fda approval of sklice ( Ivermectin)lotion for the treatment of head lice
Mobius therapeutics receives final fda approval for New glaucoma drug mitosol ( Mitomycin)
Fda approves zioptan Tafluprost ophthalmic solution), merck's once-daily, preservative-free ophthalmic medication
Fda approves korlym ( Mifepristone) for patients with endogenous cushing's syndrome
U.S. Fda approves lower dose formulation of angeliq Drospirenone and estradiol) tablets
Fda approves flumist Influenza virus vaccine, live, intranasal) to prevent seasonal influenza
Aptalis pharma announces fda approval of ultresa ( Pancrelipase) delayed release capsules
Discovery labs announces fda approval of surfaxin ( Lucinactant) for prevention of respiratory distress syndrome
U.S. Fda approves natazia Dienogest and estradiol valerate) first and only oral contraceptive demonstrated to treat heavy menstrual bleeding Hmb)
Fda approves binosto(alendronate), first and only effervescent osteoporosis treatment in a buffered solution
Teva announces fda approval of qnasl ( Beclomethasone dipropionate), a new nonaqueous nasal aerosol, for the treatment of allergic rhinitis
Fda approves intelence ( Etravirine) tablets for treatment-experienced pediatric patients with hiv-1, following priority review
Affymax and takeda announce fda approval of omontys ( Peginesatide) injection for the treatment of anemia due to chronic kidney disease Ckd) in adult patients on dialysis
Fda approves levemir ( Insulin detemir) pregnancy category change for women with diabetes
Neupro ( Rotigotine )approved by u.S. Fda for parkinson's disease and restless legs syndrome
Fda approves amyvid Florbetapir f 18 injection) for use in patients being evaluated for alzheimer's disease and other causes of cognitive decline Liraglutide [rdna] injection Victoza ( Liraglutide) label updated to include data showing superior efficacy when compared to januvia
Novartis drug afinitor ( Everolimus) approved By fda as first medication to treat patients with non-cancerous kidney tumors associated with tsc
Fda approves votrient ( Pazopanib) for advanced soft tissue sarcoma
Fda approves stendra ( Avanafil) for erectile dysfunction
Fda approves levaquin ( Levofloxacin) as an antibacterial treatment for plague
Fda approves new orphan drug elelyso ( Taliglucerase alfa) to treat a form of gaucher disease
Meda announces dymista Azelastine and fluticasone) approved by the fda for allergic rhinitis
Fabior ( Tazarotene) fda approval history for acne
Digestive care, inc. Announces fda approval of pertzye ( Pancrelipase) delayed-release capsules
Fda approves levemir ( Insulin detemir) for expanded use in children two to five years of age with type 1 diabetes
Gsk and xenoport receive fda approval for Horizant for postherpetic neuralgia
Fda approves perjeta ( Pertuzumab) for people with her2-positive metastatic breast cancer
Menhibrix Meningococcal groups c and y and haemophilus b tetanus toxoid conjugate vaccine) fda approval history
Fda approves lyrica ( Pregabalin) for the management of neuropathic pain associated with spinal cord injury based on priority review
Baxter announces fda approval for Gammagard liquid Immune globulin infusion ( Human)) as a treatment for multifocal motor neuropathy
Fda approves belviq ( Lorcaserin) to treat some overweight or obese adults
Fda approves truvada for reducing the risk of sexually acquired hiv infection
- Sodium picosulfate, magnesium oxide and citric acid) for oral solution
Fda approves prepopik Sodium picosulfate, magnesium oxide and citric acid) for oral solution )for colonoscopy prep
Fda approves truvada Emtricitabine and tenofovir) for reducing the risk of sexually acquired hiv infection
Fda approves prepopik(sodium picosulfate, magnesium oxide and citric acid) for oral solution for colonoscopy prep
Fda approves weight-management drug qsymia ( Phentermine and topiramate)
Fda approves kyprolis ( Carfilzomib) for patients with advanced multiple myeloma
Fda approves afinitor ( Everolimus) for advanced breast cancer
Fda approves tudorza ( Aclidinium bromide) pressair to treat chronic obstructive pulmonary disease
Amarin announces fda approval of vascepa ( Icosapent ethyl) capsules for the reduction of triglyceride levels in adult patients with severe hypertriglyceridemia
Horizon pharma announces fda approval of rayos ( Prednisone) delayed-release tablets for rheumatoid arthritis and multiple additional indications
Fda approves zaltrap ( Ziv-aflibercept) for metastatic colorectal cancer
Fda approves marqibo Vincristine sulfate liposomes) for philadelphia chromosome negative acute lymphoblastic leukemia
Fda approves lucentis Ranibizumab injection) for treatment of diabetic macular edema ( Dme)
Sanofi announces fda approval for Auvi-q(epinephrine), first voice-guided epinephrine auto-injector for patients with life-threatening allergies
Fda approves updated prescribing information for tradjenta ( Linagliptin) tablets for add-on therapy to insulin in adults with type 2 diabetes
Reckitt benckiser pharmaceuticals inc. Announces fda approval of two new dosage strengths of suboxone Buprenorphine and naloxone) sublingual film C-iii) for maintenance treatment of opioid dependence
Fda approves mallinckrodt's exalgo Hydromorphone hcl) extended-release tablets 32 mg ( Cii) for opioid-tolerant patients with moderate-to-severe chronic pain
Fda approves new combination pill stribild Cobicistat, elvitegravir, emtricitabine and tenofovir)for hiv treatment
Fda approves nucynta er ( Tapentadol) extended-release oral tablets for the management of neuropathic pain associated with diabetic peripheral neuropathy
Fda approves afinitor disperz ( Everolimus)- first drug formulated for children with rare brain tumor
Fda approves tbo-filgrastim for severe neutropenia in certain cancer patients
Fda approves linzess ( Linaclotide)to treat certain cases of irritable bowel syndrome and constipation
Fda approves xtandi ( Enzalutamide)for late-stage castration-resistant prostate cancer
Higher dose of novartis drug exelon ( Rivastigmine) patch approved by fda for patients with mild to moderate alzheimer's disease
Fda approves bosulif ( Bosutinib)for chronic myelogenous leukemia
Fda approves new multiple sclerosis treatment aubagio ( Teriflunomide)
Fda approves new indication for prolia ( Denosumab) for the treatment of bone loss in men with osteoporosis at high risk for fracture
Fda approves stivarga ( Regorafenib) for advanced colorectal cancer
Fda approves humira ( Adalimumab) to treat ulcerative colitis
Nextwave pharmaceuticals receives fda approval of quillivant xr(methylphenidate) for once-daily treatment of adhd
Sigma-tau pharmaceuticals, inc. Receives fda approval of cystaran Cysteamine ophthalmic solution) 0.44%
Fda approves abraxane Paclitaxel protein-bound) for the first-line treatment of advanced non-small cell lung cancer
Fda approves jetrea ( Ocriplasmin) for symptomatic vitreomacular adhesion in the eyes
Fda approves fycompa ( Perampanel) to treat seizures
Fda approves synribo ( Omacetaxine mepesuccinate) for chronic myelogenous leukemia
Fda expands use of xarelto ( Rivaroxaban) to treat, reduce recurrence of blood clots
Fda approves xeljanz ( Tofacitinib) for rheumatoid arthritis
Fda has approved Promacta Eltrobopag) for the treatment of thrombocytopenia Low blood platelet counts) in patients with chronic hepatitis c
Fda approves flucelvax Influenza virus vaccine) - first seasonal influenza vaccine manufactured using cell culture technology
Fda approves cometriq ( Cabozantinib) to treat rare type of thyroid cancer
Fda has approved Evarrest Fibrin sealant patch), a novel product that rapidly and reliably aids in stopping problematic bleeding during surgery.
Fda expands zytiga’s use for late-stage prostate cancer
Fda approves iclusig ( Ponatinib) to treat two rare types of leukemia
Fda approves raxibacumab to treat inhalational anthrax
Fda approves signifor ( Pasireotide), a new orphan drug for cushing’s disease
Fda approves glaxosmithkline's fluarix quadrivalent Influenza virus vaccine, inactivated) - four-strain seasonal influenza vaccine for use in the u.S.
Fda approves adasuve ( Loxapine) inhalation powder for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults
Fda approves biotest's bivigam, an intravenous immune globulin ( Human), 10% liquid
Fda expands tamiflu's ( Oseltamivir) use to treat children younger than one year
Fda approves gattex(teduglutide) to treat short bowel syndrome
Fda approves varizig Varicella zoster immune globulin) for reducing chickenpox symptoms
Fda approves juxtapid ( Lomitapide) - new orphan drug for rare cholesterol disorder
Fda approves eliquis ( Apixaban) to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation
Fda approves sirturo ( Bedaquiline) to treat multi-drug resistant tuberculosis
Fda approves fulyzaq ( Crofelemer) - first anti-diarrheal drug for hiv/aids patients Fda approved Drugs in 2011 Tocilizumab injection Fda approves actemra ( Tocilizumab) for the treatment of moderately to severely active rheumatoid arthritis
Hiv/aids update - atripla Efavirenz, emtricitabine and tenofovir disoproxil fumarate) label update reflects new efficacy, safety and resistance data in treatment experienced patients
Fda approves ampyra ( Dalfampridine)to improve walking in adults with multiple sclerosis Liraglutide [rdna] injection Fda approves novo-nordisk's diabetes drug victoza ( Liraglutide)
U.S. Food and drug administration approves labeling update for prezista ( Darunavir) to include 96-week data in hiv-1 infected adult patients
Gsk's tykerb ( Lapatinib ditosylate) receives accelerated approval for First-line combination treatment of metastatic breast cancer
Labopharm receives fda approval for Oleptro ( Trazodone)
Auxilium announces US Food and Drug Administrationapproval for Xiaflex ( Collagenase clostridium histolyticum) for the treatment of dupuytren's contracture
Fda approves once-a-day lamictal xr ( Lamotrigine) as add-on epilepsy therapy for primary generalized tonic-clonic seizures
Fda approves crestor ( Rosuvastatin calcium) to reduce stroke, heart attack risk
Fda approves benicar ( Olmesartan medoxomil) for the treatment of high blood pressure in children and adolescents aged 6-16
Abbott receives u.S. Fda approval for Heat-stable norvir ( Ritonavir) tablets
Fda approves rituxan ( Rituximab) to treat chronic lymphocytic leukemia
Novartis gets us approval for Menveo ( Meningococcal conjugate vaccine) meningitis vaccine
U.S. Food and drug administration approves cayston Aztreonam for inhalation solution) for the improvement of respiratory symptoms in cystic fibrosis patients with pseudomonas aeruginosa
Fda approves prevnar 13 Pneumococcal 13-valent conjugate vaccine) pneumococcal disease vaccine
Fda approves vpriv ( Velaglucerase alfa) to treat gaucher disease
Fda expands use of prevnar 13 Pneumococcal 13-valent conjugate vaccine)vaccine for people ages 50 and older
Fda approves exaglo Hydromorphone hcl) extended-release tablets
Novo nordisk receives fda approval for Norditropin flexpro for growth hormone treatment
Csl behring receives fda approval of hizentra, first 20 percent subcutaneous immunoglobulin therapy
Botox Onabotulinumtoxina) receives fda approval for Treatment of upper limb spasticity in adults
Fda approves five-day dosing regimen for dacogen ( Decitabine) for injection, offering a new outpatient dosing option for myelodysplastic syndromes ( Mds)
Fda approves watson's trelstar 22.5 mg, the first and only 6-month intramuscular gnrh agonist for the palliative treatment of advanced prostate cancer
Somaxon announces fda approval of silenor ( Doxepin) for the treatment of insomnia
Fda approves carbaglu to treat condition that causes elevated ammonia levels
Galderma received fda approval of differin ( Adapalene) lotion, 0.1%, the first retinoid available in lotion formulation
Once-daily mirapex er now approved by fda for both early and advanced parkinson's disease
Fda approves new use of xifaxan for patients with liver disease
Fda approves zyclara ( Imiquimod) cream, 3.75% for the treatment of actinic keratoses
Fda approves asclera to treat small varicose veins
Fda approves zyclara ( Imiquimod) cream, 3.75% for the treatment of external genital warts
Fda approves zyclara ( Imiquimod) cream, 2.5% for the treatment of actinic keratoses
Fda approves new formulation for oxycontin ( Oxycodone)
Fda approves pancreatic enzyme product, pancreaze ( Pancrelipase)
Fda approves oravig ( Miconazole) buccal tablets for treatment of oropharyngeal candidiasis
Fda approves tarceva ( Erlotinib) as a maintenance therapy for advanced non-small cell lung cancer
Csl behring receives fda approval to extend shelf life for privigen Immune globulin intravenous ( Human)) from 24 to 36 months
Novartis receives us fda approval for Zortress ( Everolimus) to prevent organ rejection in adult kidney transplant recipients
Abbott receives fda approval for Once-daily dosing of kaletra ( Lopinavir / ritonavir) for treatment-experienced patients
Fda approves provenge Sipuleucel-t) - a cellular immunotherapy for men with advanced prostate cancer
Fda approved vimovo for arthritis patients at risk of developing nsaid-associated gastric ulcers
Abbott receives fda approval for Creon ( Pancrelipase) to include dosing information for patients with chronic pancreatitis and pancreatectomy
Fda approves natazia Dienogest and estradiol valerate) - new combination product oral contraceptive
Allergan receives fda approval for Zymaxid ( Gatifloxacin) ophthalmic solution
Fda approves lumizyme ( Alglucosidase alfa) for late-onset pompe disease
Cysview Hexaminolevulinate hcl) approved by the fda for cystoscopic detection of papillary bladder cancer
Fda approves amgen's prolia ( Denosumab) for treatment of postmenopausal women with osteoporosis at high risk for fracture
Fda approves jalyn Dutasteride and tamsulosin) , a fixed-dose combination of dutasteride and tamsulosin, for symptomatic bph in men with an enlarged prostate
Jevtana ( Cabazitaxel) injection approved by u.S. Fda after priority review
Novartis international ag ( Ch) - fda approves tasigna ( Nilotinib) for newly diagnosed chronic myeloid leukemia patients, data demonstrate major advance over glivec
Fda approves staxyn Vardenafil hcl) orally disintegrating tablets for erectile dysfunction ( Ed)
Forest and merz announce fda approval of namenda ( Memantine hydrochloride) xr for the treatment of moderate to severe dementia of the alzheimer's type
Fda approves lucentis Ranibizumab injection) for the treatment of macular edema following retinal vein occlusion
Fda approves merck's dulera Mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol for the treatment of asthma in patients 12 years of age and older
Purdue pharma l.P. Receives fda approval for Butrans ( Buprenorphine) transdermal system ciii
Fda approves alsuma ( Sumatriptan) auto-injector
Fda approves new indications for prolia ( Denosumab) for the treatment of bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy
Fda approves strativa pharmaceuticals' zuplenz ( Ondansetron) oral soluble film
Three rivers pharmaceuticals announces fda approval of expanded labeling of infergen ( Interferon alfacon-1)
Kamada wins fda approval for Glassia Alpha1-proteinase inhibitor ( Human)) - a new liquid, ready-to-use treatment for alpha-1 antitrypsin deficiency
Fda approves daytrana Methylphenidate transdermal system) cii for the treatment of adhd in adolescents
Stiefel, a gsk company, receives fda approval of veltin Clindamycin phosphate and tretinoin) gel 1.2%/0.025%
Eisai inc. And pfizer inc announce u.S. Fda approval for New higher-dose aricept Donepezil hcl) 23 mg tablet for the treatment of moderate-to-severe alzheimer's disease
Fda approves tribenzor Amlodipine, hydrochlorothiazide and olmesartan) , a new three-in-one combination product for the treatment of high blood pressure
Fda approves lastacaft Alcaftadine ophthalmic solution) for prevention of itching associated with allergic conjunctivitis
Fda approves cuvposa ( Glycopyrrolate) for chronic drooling in children
Abbott's simcor Niacin extended-release/simvastatin) receives fda approval for New dosage strengths
Fda approves new taxotere ( Docetaxel) injection concentrate formulation
Fda approves suprep Sodium sulfate, potassium sulfate, magnesium sulfate) bowel prep kit
Fda approves longer use of valcyte ( Valganciclovir) for adult kidney transplant patients at high risk of developing cytomegalovirus ( Cmv) disease
Fda approves ella ( Ulipristal acetate) tablets for prescription emergency contraception
Novartis receives fda approval of tekamlo Aliskiren and amlodipine), a single-pill combination of aliskiren and amlodipine to treat high blood pressure
Reckitt benckiser pharmaceuticals inc. Receives fda approval for Suboxone Buprenorphine and naloxone) sublingual film c-iii
Merck receives approval from fda for expanded indications for atypical antipsychotic medication saphris ( Asenapine) sublingual tablets
Fda approves new dosing for faslodex ( Fulvestrant) injection in treatment of metastatic breast cancer in hr+ postmenopausal women
Fda approves pediatric use of protopam chloride ( Pralidoxime chloride) chemical poisoning treatment
Fda approves krystexxa ( Pegloticase) for gout
Novartis gains fda approval for gilenya ( Fingolimod), a novel first-line multiple sclerosis treatment shown to significantly reduce relapses and delay disability progression
Allergan receives fda approval for Ozurdex ( Dexamethasone) as treatment option for non-infectious uveitis affecting the posterior segment of the eye
Shionogi announces fda approval of kapvay ( Clonidine hydrochloride) - the first and only therapy approved for use with stimulant medication for the treatment of adhd
Allergan, inc. Receives fda approval for Lumigan 0.01% as first-line therapy indicated for the reduction of elevated intraocular pressure in glaucoma patients
United states food and drug administration approves aridol ( Mannitol)
Warner chilcott announces fda approval of atelvia ( Risedronate sodium) next generation actonel
Stiefel, a gsk company, receives fda approval of sorilux ( Calcipotriene) foam, 0.005%
Fda approves vivitrol ( Naltrexone) to treat opioid-dependent patients
Talecris biotherapeutics receives fda approval for Gamunex-c Immune globulin intravenous and subcutaneous)
Fda approves h.P. Acthar gel ( Corticotropin) for the treatment of infantile spasms
U.S. Food and drug administration approves baraclude ( Entecavir) as a treatment for chronic hepatitis b patients with evidence of decompensated liver disease
Fda approves pradaxa ( Dabigatran etexilate) to prevent stroke in people with atrial fibrillation
Ista pharmaceuticals receives fda approval for Bromday ( Bromfenac)
Warner chilcott announces fda approval of new oral contraceptive lo loestrin fe Norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate)
Fda approves additional medical indication for sprycel ( Dasatinib)
Fda approves latuda ( Lurasidone) to treat schizophrenia in adults
Avanir pharmaceuticals announces fda approval of nuedexta Dextromethorphan and quinidine)
Fda approves teflaro ( Ceftaroline fosamil) for bacterial infections
Fda approves new indication for afinitor ( Everolimus)
Cadence pharmaceuticals announces fda approval of ofirmev ( Acetaminophen) injection for the management of pain and fever
Fda clears cymbalta ( Duloxetine) to treat chronic musculoskeletal pain
Kombiglyze xr Saxagliptin and metformin hcl extended-release) tablets approved in the u.S. For the treatment of type 2 diabetes mellitus in adults
Fda approves egrifta Tesamorelin for injection): first and only treatment for the reduction of excess abdominal fat in hiv-infected patients with lipodystrophy
Fda approves vyvanse ( Lisdexamfetamine dimesylate) capsules cii for the treatment of adhd in adolescents
Fda approves halaven ( Eribulin mesylate) for late-stage breast cancer
Fda approves amgen's xgeva ( Denosumab) for the prevention of skeletal-related events in patients with bone metastases from solid tumors
Prism pharmaceuticals receives fda approval of ready-to-use nexterone Amiodarone hcl) premixed injection
Fda approves moxeza ( Moxifloxacin) for bacterial conjunctivitis
Fda approves movement disorder drug from cns therapeutics: gablofen Baclofen injection) for the treatment of severe spasticity
Lilly and acrux receive fda approval for Axiron ( Testosterone) topical solution ciii
Cubist pharmaceuticals receives fda approval for 2-minute iv injection of cubicin ( Daptomycin )
Fda approves prezista ( Darunavir) once-daily dosing for hiv-1 treatment-experienced adults with no darunavir resistance-associated mutations
Novartis gains fda approval for Amturnide Aliskiren, amlodipine and hydrochlorothiazide), a triple-combination pill to treat high blood pressure in patients uncontrolled on two medications
Endo pharmaceuticals receives fda approval for Fortesta ( Testosterone) gel as a class iii product for topical use for men with low testosterone Fda approved Drugs from 2009 triamcinolone inhalation Collegium pharmaceutical announces fda approval of allernaze ( Triamcinolone acetonide), a nasal inhaled steroid for the treatment of allergic rhinitis
Anesiva announces fda approval of snda to expand zingo Lidocaine hydrochloride monohydrate) indication to include adults
Forest and cypress announce fda approval of savella ( Milnacipran) for the management of fibromyalgia
Csl behring receives fda approval of riastap Fibrinogen concentrate ( Human)) , first and only approved treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency
Watson's gelnique ( Oxybutynin chloride) gel 10% approved by fda for the treatment of overactive bladder
Fda approves kapidex ( Dexlansoprazole) for the treatment of gerd
Galderma wins fda approval for Vectical ointment, a novel topical therapy for mild-to-moderate plaque psoriasis
Hiv/aids update - traditional approval of isentress ( Raltegravir)
United states food and drug administration ( Fda) approves iv formulation of temodar ( Temozolomide)
Atryn (Antithrombin [recombinant]) approved by the fda
Fda approves uloric ( Febuxostat) for the chronic management of hyperuricemia in patients with gout
Fda approves symbicort Budesonide and formoterol) for chronic obstructive pulmonary disease ( Copd)
Orexo's edluar ( Zolpidem) receives fda approval for the treatment of insomnia
Forest laboratories, inc. Announces fda approval of lexapro ( Escitalopram oxalate) for the treatment of major depressive disorder in adolescents
Fda approves symbyax Fluoxetine and olanzapine) as first medication for treatment-resistant depression
Fda approves new indication for wyeth's tygacil ( Tigecycline) for the treatment of adult patients with community-acquired bacterial pneumonia
Afinitor ( Everolimus) approved In us as first treatment for patients with advanced kidney cancer after failure of either sunitinib or sorafenib
Intercell announces fda approval of ixiaro Japanese encephalitis virus vaccine, inactivated, adsorbed) , a novel vaccine to prevent japanese encephalitis
Coartem Artemether and lumefantrine) receives fda approval becoming first artemisinin-based combination treatment ( Act) for malaria in the us
Sciele pharma announces fda approval of ulesfia ( Benzyl alcohol) lotion 5%, first prescription non-neurotoxic head lice treatment
Simponi ( Golimumab) receives fda approval as first once-monthly anti-tnf for treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis
Fda approves dysport Abobotulinumtoxina) for therapeutic and aesthetic uses
Fda approves exforge hct Amlodipine, valsartan and hydrochlorothiazide) - the only high blood pressure treatment to combine three medications in a single pill
Fda approves cetraxal Ciprofloxacin otic) otic solution
Fda grants accelerated approval of avastin ( Bevacizumab) for brain cancer ( Glioblastoma) that has progressed following prior therapy
Veroscience announces fda approval of cycloset ( Bromocriptine mesylate) for treatment of type 2 diabetes
Fda approves fanapt ( Iloperidone) to treat schizophrenia
Fda approves lamictal ( Lamotrigine) odt orally disintegrating tablets
Azor Amlodipine and olmesartan) receives fda approval as first-line treatment for high blood pressure
Fda approves actoplus met xr Pioglitazone hcl and metformin hcl extended-release) tablets for the treatment of type 2 diabetes
Ucb's cimzia ( Certolizumab pegol) approved by the u.S. Fda for adult patients suffering from moderate to severe rheumatoid arthritis
Novartis receives approval from fda to market prevacid ( Lansoprazole) 24hr as first and only otc proton pump inhibitor in original prescription formulation
Fda grants approval for Use of risperdal ( Risperidone) consta as both a monotherapy and adjunctive therapy in the maintenance treatment of bipolar I disorder
Fda approves samsca ( Tolvaptan), the first and only oral vasopressin antagonist to treat patients with clinically significant hypervolemic and euvolemic hyponatremia
Fda approves adcirca ( Tadalafil) tablets for the treatment of pulmonary arterial hypertension
Fda grants full approval for Sprycel ( Dasatinib) for the treatment of adults with chronic myeloid leukemia who are resistant or intolerant to prior therapies including gleevec
Astellas receives fda approval for Use of prograf ( Tacrolimus) in conjunction with mycophenolate mofetil Mmf) in kidney transplant recipients
Bausch & lomb receives fda approval of besivance ( Besifloxacin), new topical ophthalmic antibacterial for the treatment of bacterial conjunctivitis 'pink eye')
Fda approves reclast ( Zoledronic acid) to prevent osteoporosis in postmenopausal women with convenient less frequent dosing
Cumberland pharmaceuticals announces fda approval of caldolor ( Ibuprofen)
New biological therapy ilaris ( Canakinumab) approved in us to treat children and adults with caps, a serious life-long auto-inflammatory disease
Allergan receives fda approval for Ozurdex ( Dexamethasone) biodegradable, injectable steroid implant with extended drug release for retinal disease
Fda approves cambia ( Diclofenac potassium)for migraine
Fda approves feraheme ( Ferumoxytol) to treat iron deficiency anemia in adult chronic kidney disease patients
Fda approves multaq ( Dronedarone) for patients with atrial fibrillation or atrial flutter
Lilly receives fourth fda approval for Alimta Pemetrexed for injection) as maintenance therapy for nonsquamous non-small cell lung cancer
Daiichi sankyo and lilly receive u.S. Fda approval for Effient ( Prasugrel)
Fda approves plan b one-step ( Levonorgestrel) , a new one-pill emergency contraceptive
Biodelivery sciences and meda announce fda approval of onsolis ( Fentanyl)
Fda approves novolog ( Insulin aspart) labeling update
Fda approves tekturna hct Aliskiren and hydrochlorothiazide) as initial treatment in patients unlikely to achieve their blood pressure goals with a single agent
Allergan receives fda approval for Acuvail ( Ketorolac tromethamine) ophthalmic solution for the treatment of pain and inflammation following cataract surgery
Fda approves expanded use of lilly's forteo [teriparatide Rdna origin) injection] to treat glucocorticoid-induced osteoporosis
Fda approves sculptra Injectable poly-l-lactic acid) aesthetic, a facial injectable for correction of nasolabial folds and other facial wrinkles
Fda approves tyvaso ( Treprostinil) inhalation solution for the treatment of pulmonary arterial hypertension
Fda approves colcrys ( Colchicine) for acute gout, mediterranean fever
Fda approves onglyza ( Saxagliptin) for type 2 diabetes
The us fda approves lipsovir Acyclovir and hydrocortisone) for marketing and sales in us
Fda approves avastin for the most common type of kidney cancer
Invega approved as the first and only treatment for schizoaffective disorder
Fda approves livalo ( Pitavastatin) for primary hypercholesterolemia and combined dyslipidemia
Fda approves embeda Morphine sulfate and naltrexone hydrochloride) for management of moderate to severe chronic pain
Schering-plough announces fda approval of saphris ( Asenapine)
Us fda approves extavia ( Interferon beta-1b) - the first in a new portfolio of planned ms therapies from novartis to help patients with this devastating disease
- Haemophilus b conjugate vaccine Tetanus toxoid conjugate)
Fda approves gsk's hib vaccine,hiberix Haemophilus b conjugate vaccine Tetanus toxoid conjugate))
Lundbeck inc. Announces fda marketing approval for Sabril ( Vigabatrin) for the treatment of two difficult-to-treat epilepsies
Fda approves xyzal Levocetirizine dihydrochloride)for use in children age six months and older for the relief of perennial allergic rhinitis and chronic idiopathic urticaria
Eurand granted fda approval for Zenpep ( Pancrelipase)
Fda approves valcyte ( Valganciclovir hydrochloride) to prevent cytomegalovirus ( Cmv) disease in pediatric patients who receive heart or kidney transplants
Shire announces fda approval of once-daily intuniv ( Guanfacine) extended release tablets for the treatment of adhd in children and adolescents aged 6 to 17
Fda approves zevalin ( Ibritumomab tiuxetan) expanded label as part of first-line therapy in treatment of follicular non-hodgkin's lymphoma
Salix receives fda marketing approval for Metozolv odt ( Metoclopramide) for relief of diabetic gastroparesis and symptomatic documented gerd
Ista pharmaceuticals' bepreve ( Bepotastine) receives fda approval for the treatment of ocular itching due to allergies
Theravance and astellas announce fda approval of vibativ ( Telavancin) for the treatment of complicated skin and skin structure infections
Sirion therapeutics announces fda approval of zirgan Ganciclovir ophthalmic gel) 0.15% for herpetic keratitis
Novartis receives fda approval for valturna Aliskiren and valsartan), a single-pill combination of valsartan and aliskiren, to treat high blood pressure
Fda approves folotyn ( Pralatrexate) for treatment of peripheral t-cell lymphoma
Fda approves stelara ( Ustekinumab) to treat psoriasis
Merck receives approval from fda for expanded indications for atypical antipsychotic medication saphris ( Asenapine) sublingual tablets
Fda approves additional use for iud mirena ( Levonorgestrel) to treat heavy menstrual bleeding in iud users
Welchol Colesevelam hcl) receives fda approval to lower ldl cholesterol in pediatric patients with heterozygous familial hypercholesterolemia
Csl behring announces fda approval of berinert ( C1 esterase inhibitor ( Human)), first and only therapy approved for the treatment of acute abdominal and facial attacks of hereditary angioedema in u.S.
U.S. Food and drug administration approves crestor ( Rosuvastatin calcium) for use in pediatric patients with heterozygous familial hypercholesterolemia
Fda approves elitek ( Rasburicase) for management of plasma uric acid levels in adults with leukemia, lymphoma, and solid tumors receiving anti-cancer therapy
Fda approves seasonal influenza vaccine fluarix Influenza virus vaccine, inactivated) for pediatric use
Fda approves new use for micardis ( Telmisartan) in cardiovascular risk reduction
Fda approves twynsta ( Telmisartan/amlodipine) for hypertension
Fda approves glaxosmithkline’s votrient ( Pazopanib) for advanced renal cell cancer
Fda approves colcrys Colchicine, usp) for prevention of gout flares
Fda approves arzerra ( Ofatumumab) for chronic lymphocytic leukemia
Byetta ( Exenatide) approved For expanded use as first-line treatment for type 2 diabetes
Fda approves pennsaid ( Diclofenac sodium) topical solution
Fda approves gloucester pharmaceuticals' istodax ( Romidepsin) for patients with cutaneous t-cell lymphoma
Fda approves labeling update for reyataz ( Atazanavir sulfate) capsules to include 96-week data for previously untreated hiv-1 infected adult patients
Fda expands approved use of influenza a ( H1n1) monovalent vaccine H1n1 influenza virus vaccine) to include infants and children
Xanodyne announces fda approval of lysteda ( Tranexamic acid) for treatment of women with heavy menstrual bleeding
Neurogesx receives fda approval of qutenza ( Capsaicin) 8% patch for treatment of postherpetic neuralgia Phn)
Fda approves intravenous formulation of pfizer's revatio ( Sildenafil) for the treatment of pulmonary arterial hypertension
U.S. Food and drug administration approves abilify ( Aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients Ages 6 to 17 years)
Fda approves cymbalta ( Duloxetine) for maintenance treatment of generalized anxiety disorder
Fda grants accelerated approval of istodax ( Romidepsin) as treatment for patients with peripheral t-cell lymphoma who have received at least one prior therapy
Fda approves addition of sustained overall survival benefit to label for velcade ( Bortezomib) for injection for patients with previously untreated multiple myeloma
Fda approves otc version of heartburn drug zegerid Omeprazole and sodium bicarbonate)
Fda approves 10 mcg dose of vagifem ( Estradiol) for the treatment of atrophic vaginitis due to menopause
Dyax announces fda approval of kalbitor ( Ecallantide) for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older
Fda approves seroquel xr ( Quetiapine) for add-on treatment of major depressive disorder
Fda approves lilly's zyprexa ( Olanzapine) for two adolescent indications
Octapharma usa announces fda approval of wilate Von willebrand factor/coagulation factor viii complex ( Human))- the first replacement therapy developed specifically for von willebrand disease
Fda approves lilly's zyprexa relprevv ( Olanzapine) for treatment of schizophrenia in adults
Fda approves newly revised prescribing information for azilect ( Rasagiline mesylate) reducing medication and food restrictions
Fda approves spiriva ( Tiotropium bromide) handihaler for the reduction of copd exacerbations Fda approved Drugs from 2008 Tadalafil Fda approves cialis ( Tadalafil) for once daily use for the treatment of erectile dysfunction
Fda approves tysabri ( Natalizumab) to treat moderate-to-severe crohn's disease
Alvesco ( Ciclesonide) gains fda approval for the u.S. Market
- Prednisolone acetate Oral suspension)
Taro receives fda approval of new drug application for flo-pred Prednisolone acetate oral suspension)
Fda approves zymogenetics' recothrom Thrombin, topical ( Recombinant))
Abbott's humira ( Adalimumab) receives fda approval for moderate to severe chronic plaque psoriasis
Fda approves intelence ( Etravirine) for hiv combination therapy
Tekturna hct Aliskiren and hydrochlorothiazide) , a single-tablet combination of tekturna and a diuretic, receives us approval for Treatment of high blood pressure
Fda approves additional indication for astellas' mycamine ( Micafungin sodium)
Cangene's recombinant human growth hormone accretropin ( Somatropin Rdna origin)) approved by the US Food and Drug Administration
Fda approves asmanex twisthaler Mometasone furoate inhalation powder) for the once daily maintenance treatment of asthma in children ages 4-11
Abbott receives fda approval for Simcor Niaspan / simvastatin), a novel combination medicine for comprehensive cholesterol management
Fda approves xyzal Levocetirizine dihydrochloride) oral solution for the relief of seasonal and year round allergies and chronic idiopathic urticaria
Abbott receives fda approval for Humira ( Adalimumab) for polyarticular juvenile idiopathic arthritis
Fda grants accelerated approval of avastin ( Bevacizumab) in combination with paclitaxel chemotherapy for first-line treatment of advanced her2-negative breast cancer
Fda approves nexium ( Esomeprazole) for use in children ages 1-11 years
Fda approves arcalyst ( Rilonacept) - new orphan drug for treatment of cryopyrin-associated periodic syndromes ( Caps)
U.S. Food and drug administration approves abilify ( Aripiprazole) for the acute treatment of manic and mixed episodes associated with bipolar I disorder in pediatric patients 10 to 17 years of age)
Fda approves pristiq ( Desvenlafaxine) for the treatment of adult patients with major depressive disorder
Fda approves aloxi Palonosetron hcl) injection for prevention of postoperative nausea and vomiting
Fda approves new drug application for fusilev ( Levoleucovorin), spectrum's first proprietary oncology drug
Fda approves artiss ( Fibrin sealant ( Human)) medical adhesive to treat burn patients
Fda approves rotarix Rotavirus vaccine, live attenuated) vaccine to prevent gastroenteritis caused by rotavirus
Cv therapeutics and astellas announce fda approval for Lexiscan ( Regadenoson) injection
Alcon's patanase ( Olopatadine hydrochloride) nasal spray approved by fda for treatment of nasal allergy symptoms
Treximet Sumatriptan and naproxen sodium) tablets approved by fda for acute treatment of migraine
Cimzia ( Certolizumab pegol) approved in the us for the treatment of moderate to severe crohn's disease
Fda approves vyvanse ( Lisdexamfetamine dimesylate), the first and only once-daily prodrug stimulant to treat adhd in adults
Biovail receives fda approval for Aplenzin ( Bupropion hydrobromide)
Progenics and wyeth announce fda has approved relistor ( Methylnaltrexone bromide)
Fda approves strattera ( Atomoxetine) for maintenance of adhd in children and adolescents
U.S. Food and drug administration approves abilify ( Aripiprazole) for add-on treatment to lithium or valproate in the acute treatment of adults with manic and mixed episodes of bipolar I disorder with or without psychotic features
Novalar pharmaceuticals, inc. Receives fda approval for Oraverse ( Phentolamine mesylate)
Fda approves taclonex Calcipotriene and betamethasone dipropionate) scalp - once daily therapy for treatment of moderate to severe scalp psoriasis
Fda approves astrazeneca's seroquel ( Quetiapine) for maintenance treatment in bipolar disorder
Adolor and glaxosmithkline announce fda approval of entereg ( Alvimopan) for the management of postoperative ileus ( Poi)
Fda approves aciphex Rabeprazole sodium) 20 mg for short-term treatment of gerd in adolescents
Fda broadens us indication for once-yearly reclast ( Zoledronic acid) as only osteoporosis treatment approved For prevention of fractures after a hip fracture
U.S. Fda approves requip ( Ropinirole) xl, the first and only oral once-daily non-ergot dopamine agonist for parkinson's disease
Fda approves cymbalta ( Duloxetine) for the management of fibromyalgia
Allergan receives US Food and Drug Administrationapproval for Trivaris Triamcinolone acetonide injectable suspension) 80 mg/ml
Fda approves glaxosmithkline's avodart ( Dutasteride) in combination with tamsulosin for the treatment of symptomatic enlarged prostate
Fda approves velcade ( Bortezomib) for injection for patients with previously untreated multiple myeloma
Fda approves prandimet Replaglinide and metformin a fixed-dose combination) tablet for treatment of type 2 diabetes
Sirion therapeutics announces fda approval of durezol ( Difluprednate) for treatment of postoperative ocular inflammation and pain
New aptivus ( Tipranavir) oral solution approved for treatment-experienced pediatric and adolescent hiv patients
Fda approves kinrix Diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) - new combination vaccine for children
Fda approves concerta ( Methylphenidate hcl) extended-release tablets for treatment of adhd ( Attention deficit hyperactivity disorder) in adults
Photocure receives fda approval for Metvixia/aktilite photodynamic therapy
Fda approves evolence ( Dermal filler) , a new generation collagen-based facial filler
Fda approves eovist ( Gadoxetate disodium) to detect and characterize focal liver lesions
Fda approves navstel Balanced salt ophthalmic solution with hypromellose, dextrose and glutathione) intraocular irrigating solution
Noven announces final fda approval of stavzor ( Valproic acid) for the treatment of bipolar disorder, seizures and migraine headaches
Fda approves cardene ( Nicardipine) a new cardene formulation
Fda exforge Amlodipine and valsartan) approved for high blood pressure as first-line treatment
The medicines company’s cleviprex ( Clevidipine butyrate) receives fda approval
U.S. Food and drug administration approves viread ( Tenofovir disoproxil fumarate) for chronic hepatitis b in adults
Xenazine ( Tetrabenazine) approved by fda for patients with chorea associated with huntington's disease
Vidaza ( Azacitidine) receives expanded fda approval to include overall survival in higher-risk mds
Fda approves nplate ( Romiplostim) for long-term treatment of adult chronic itp
Fda approves aloxi Palonosetron hcl) capsules for prevention of acute chemotherapy-induced nausea and vomiting
Fda approves novolog mix Insulin aspart and insulin aspart protamine)
Fda approves expanded uses for gardasil Human papillomavirus quadrivalent Types 6, 11, 16, and 18) vaccine, recombinant to include preventing certain vulvar and vaginal cancers
Fda approves sancuso ( Granisetron), the first and only patch for preventing nausea and vomiting in cancer patients undergoing chemotherapy
Keppra ( Levetiracetam) xr approved in the u.S.
Fda grants approval to talecris biotherapeutics for gamunex Immune globulin intravenous ( Human)) as a treatment for neurological disorder cidp in the united states
Fda approves ge healthcare's adreview Iobenguane I 123 injection) diagnostic agent for detecting neuroendocrine tumors in children, adults
Teva's proair hfa ( Albuterol sulfate), the market leading albuterol inhaler, receives new pediatric indication
Fda grants lilly's alimta Pemetrexed for injection) third u.S. Approval
Fda approved the use of reyataz ( Atazanavir sulfate) boosted with ritonavir, in combination therapy, for previously untreated hiv-1 infected adult patients
Akorn, inc. Announces the fda approval of akten ophthalmic gel 3.5%
Watson receives us fda approval for Rapaflo ( Silodosin) for the treatment of benign prostatic hyperplasia Bph)
Fda approves new injection site for risperdal consta for schizophrenia treatment
Fda approves astrazeneca’s seroquel xr for the treatment of bipolar depression and bipolar mania in the us
Cinryze receives fda approval for Prophylaxis against hereditary angioedema attacks
Fda approves Astepro
Fda approves Acanya
U.S. Food and drug administration ( Fda) approves prezista once-daily as part of combination therapy for treatment-naive adults with hiv-1
Fda approves astellas' vaprisol Conivaptan hydrochloride injection) premixed in 5% dextrose for the treatment of hyponatremia
Fda approves duramed's loseasonique oral contraceptive
Fda approves rapid-acting insulin apidra for treatment of children with diabetes
Ucb's vimpat approved by u.S. Fda as adjunctive therapy for partial onset seizures in adults
Pfizer's toviaz ( Fesoterodine fumarate) receives fda approval for the treatment of overactive bladder
Apriso granted fda marketing approval for Maintenance of remission of ulcerative colitis
Cephalon receives fda approval for Treanda ( Bendamustine hydrochloride) to treat patients with relapsed indolent non-hodgkin's lymphoma
Fda approves promacta ( Eltrombopag), the first oral medication to increase platelet production for people with serious blood disorder
Crestor ( Rosuvastatin calcium) approved for primary dysbetalipoproteinemia
Fda approves ranexa ( Ranolazine) for first line anti anginal use
Ekr therapeutics broadens its ready-to-use cardene ( Nicardipine) product offerings with fda approval of double concentration premixed I.V. Bags
Fda approves low-dose regimen of premarin vaginal cream ( Conjugated estrogens) to treat moderate to severe postmenopausal dyspareunia - painful sexual intercourse
Fda approves banzel ( Rufinamide) as adjunctive treatment for severe epilepsy disorder
Fda approves tapentadol immediate-release tablets for relief of moderate to severe acute pain
Fda approves duramed's synthetic conjugated estrogens-a vaginal cream
Fda approves glaxosmithkline tetanus, diphtheria, whooping cough vaccine, boostrix Tetanus, diphtheria, acellular pertussis vaccine ( Tdap)), for adults
Fda approves lusedra ( Fospropofol disodium) injection for monitored anesthesia care ( Mac) sedation
Abbott receives fda approval for Trilipix ( Fenofibric acid), first and only fibrate indicated for use in combination with a statin for cholesterol management
Fda approves genzyme's mozobil ( Plerixafor)
Emergent biosolutions receives fda approval for Biothrax ( Anthrax vaccine adsorbed) supplemental biologics license application
Antisoma receives fda approval for Oforta ( Fludarabine phosphate) oral, plans commercialization deal to bring drug to us patients
Cumberland pharmaceuticals reports fda approval for Updated labeling of acetadote ( Acetylcysteine)
Fda approves gleevec ( Imatinib mesylate) to prevent recurrence of rare gastrointestinal cancer
Novadel pharma receives fda approval of Zolpimist ( Zolpidem tartrate)
Epix pharmaceuticals announces fda approval of vasovist ( Gadofosveset trisodium)
Fda approves ferring pharmaceutical's Firmagon ( Degarelix) for treatment of advanced prostate cancer
Allergan announces US Food and Drug Administration ( Fda) approval of latisse ( Bimatoprost)- first and only treatment approved by the fda for hypotrichosis of eyelashes
Labopharm announces fda approval of once-daily ryzolt ( Tramadol) for moderate to moderately severe chronic pain
Prism pharmaceuticals receives fda approval of Nexterone Amiodarone hcl) for life-threatening ventricular fibrillation and ventricular tachycardia
Galderma announces availability of Epiduo Adapalene and benzoyl peroxide) the first and only combination treatment with a retinoid and benzoyl peroxide to treat Acne Drug groups | Encyclopedia | Dictionary | Cancer drugs | OTC | Alternative meds | Drugs | Medications A-Z | FDA approved products | Portal:Pharmacology
Navigation: Wellness - Encyclopedia - Health topics - Disease Index - Drugs - World Directory - Gray's Anatomy - Keto diet - Recipes
Search WikiMD
Ad.Tired of being Overweight? Try W8MD's physician weight loss program.
Semaglutide (Ozempic / Wegovy and Tirzepatide (Mounjaro) available.
Advertise on WikiMD
WikiMD is not a substitute for professional medical advice. See full disclaimer.
Credits:Most images are courtesy of Wikimedia commons, and templates Wikipedia, licensed under CC BY SA or similar.Contributors: Dr.T
