New drug approvals
From WikiMD.com Medical Encyclopedia
Here is a list of the new drug approvals as approved by the US Food and Drug Administration.
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FDA New Drug Approvals for 2024[edit | edit source]
Novel Drug Approvals for 2023[edit | edit source]
New drug approvals for 2022[edit | edit source]
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
|---|---|---|---|---|
| 1. | Quviviq | daridorexant | 1/7/2022 | To treat insomnia |
| 2. | Cibinqo | abrocitinib | 1/14/2022 | To treat refractory, moderate-to-severe atopic dermatitis |
| 3. | Kimmtrak | tebentafusp-tebn | 1/25/2022 | To treat unresectable or metastatic uveal melanoma |
| 4. | Vabysmo | faricimab-svoa | 1/28/2022 | To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema |
| 5. | Enjaymo | sutimlimab-jome | 2/4/2022 | To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease |
| 6. | Pyrukynd | mitapivat | 2/17/2022 | To treat hemolytic anemia in pyruvate kinase deficiency |
| 7. | Vonjo | pacritinib | 2/28/2022 | To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets |
| 8. | Ztalmy | ganaxolone | 3/18/2022 | To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder |
| 9. | Opdualag | nivolumab and relatlimab-rmbw | 3/18/2022 | To treat unresectable or metastatic melanoma |
| 10. | Pluvicto | lutetium (177Lu) vipivotide tetraxetan | 3/23/2022 | To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies |
| 11. | Vivjoa | oteseconazole | 4/26/2022 | To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential |
| 12. | Camzyos | mavacamten | 4/28/2022 | To treat certain classes of obstructive hypertrophic cardiomyopathy |
| 13. | Voquezna | vonoprazan, amoxicillin, and clarithromycin | 5/3/2022 | To treat Helicobacter pylori infection |
| 14. | Mounjaro | tirzepatide | 5/13/2022 | To improve blood sugar control in diabetes, in addition to diet and exercise |
| 15. | Vtama | tapinarof | 5/23/2022 | To treat plaque psoriasis |
| 16. | Amvuttra | vutrisiran | 6/13/2022 | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| 17. | Xenpozyme | Olipudase alfa | 8/31/2022 | To treat Acid Sphingomyelinase Deficiency |
| 18. | Spevigo | spesolimab-sbzo | 9/1/2022 | To treat generalized pustular psoriasis flares |
| 19. | Daxxify | daxibotulinumtoxinA-lanm | 9/7/2022 | To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity |
| 20. | Sotyktu | deucravacitinib | 9/9/2022 | To treat moderate-to-severe plaque psoriasis |
| 21. | Rolvedon | eflapegrastim | 9/9/2022 | To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia |
| 22. | Terlivaz | terlipressin | 9/14/2022 | To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function |
| 23. | Elucirem | gadopiclenol | 9/21/2022 | To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body |
| 24. | Omlonti | oomidenepag isopropyl ophthalmic solution | 9/22/2022 | To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension |
| 25. | Relyvrio | sodium phenylbutyrate/taurursodiol | 9/29/2022 | To treat amyotrophic lateral sclerosis (ALS) |
| 26. | Lytgobi | futibatinib | 9/30/2022 | To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements |
| 27. | Imjudo | tremelimumab | 10/21/2022 | To treat unresectable hepatocellular carcinoma |
| 28. | Tecvayli | teclistamab-cqyv | 10/25/2022 | To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy |
| 29. | Elahere | mirvetuximab soravtansine-gynx | 11/14/2022 | To treat patients with recurrent ovarian cancer that is resistant to platinum therapy |
| 30. | Tzield | teplizumab-mzwv | 11/18/22 | To delay the onset of stage 3 type 1 diabetes |
| 31. | Rezlidhia | olutasidenib | 12/1/2022 | To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation |
| 32. | Krazati | adagrasib | 12/12/2022 | To treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior systemic therapy |
| 33. | Sunlenca | lenacapavir | 12/22/2022 | To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations |
| 34. | Lunsumio | mosunetuzumab-axgb | 12/22/2022 | To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma |
| 35. | Xenoview | hyperpolarized Xe-129 | 12/23/2022 | To evaluate pulmonary function and imaging |
| 36. | Briumvi | ublituximab-xiiy | 12/28/2022 | To treat relapsing forms of multiple sclerosis |
| 37. | NexoBrid | anacaulase-bcdb | 12/28/2022 | To remove eschar in adults with deep partial thickness or full thickness thermal burns |
New drug approvals for 2021[edit | edit source]
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date |
|---|---|---|---|---|
| 4. | Tepmetko | tepotinib | 2/3/2021 | To treat non-small cell lung cancer |
| 3. | Lupkynis | voclosporin | 1/22/2021 | To treat lupus nephritis |
| 2. | Cabenuva | cabotegravir and rilpivirine | 1/21/2021 | To treat HIV |
| 1. | Verquvo | vericiguat | 1/19/2021 | To treat chronic heart failure |
New drug approvals 2020[edit | edit source]
- Gemtesa is a new drug with active ingredient(s) of vibegron, US FDA approved on 12/23/2020. The FDA approved use(s) at the time of approval include: To treat overactive bladder.
- Ebanga is a new drug with active ingredient(s) of ansuvimab-zykl, US FDA approved on 12/21/2020. The FDA approved use(s) at the time of approval include: To treat ebola.
- Orgovyx is a new drug with active ingredient(s) of relugolix, US FDA approved on 12/18/2020. The FDA approved use(s) at the time of approval include: To treat advanced prostate cancer.
- Margenza is a new drug with active ingredient(s) of margetuximab (anti-HER2 mAb, US FDA approved on 12/16/2020. The FDA approved use(s) at the time of approval include: To treat HER2+ breast cancer.
- Klisyri is a new drug with active ingredient(s) of tirbanibulin, US FDA approved on 12/14/2020. The FDA approved use(s) at the time of approval include: To treat actinic Keratosis of the face or scalp
- Orladeyo is a new drug with active ingredient(s) of berotralstat, US FDA approved on 12/3/2020. The FDA approved use(s) at the time of approval include: To treat patients with hereditary angioedema.
- Gallium 68 PSMA-11 is a new drug with active ingredient(s) of Gallium 68 PSMA-11, US FDA approved on 12/1/2020. The FDA approved use(s) at the time of approval include: For detection, and localization of prostate cancer.
- Danyelza is a new drug with active ingredient(s) of naxitamab-gqgk, US FDA approved on 11/25/2020. The FDA approved use(s) at the time of approval include: To treat high-risk refractory or relapsed neuroblastoma.
- Imcivree is a new drug with active ingredient(s) of setmelanotide, US FDA approved on 11/25/2020. The FDA approved use(s) at the time of approval include: To treat obesity, and the control of hunger associated with pro-opiomelanocortin deficiency, a rare disorder that causes severe obesity that begins at an early age
- Oxlumo is a new drug with active ingredient(s) of lumasiran, US FDA approved on 11/23/2020. The FDA approved use(s) at the time of approval include: To treat hyperoxaluria type 1.
- Zokinvy is a new drug with active ingredient(s) of lonafarnib, US FDA approved on 11/20/2020. The FDA approved use(s) at the time of approval include: To treat rare conditions related to premature aging.
- Veklury is a new drug with active ingredient(s) of remdesivir, US FDA approved on 10/22/2020. The FDA approved use(s) at the time of approval include: To treat COVID-19.
- Inmazeb is a new drug with active ingredient(s) of atoltivimab, maftivimab, and odesivimab-ebgn, US FDA approved on 10/14/2020. The FDA approved use(s) at the time of approval include: To treat ebola virus.
- Gavreto is a new drug with active ingredient(s) of pralsetinib, US FDA approved on 9/4/2020. The FDA approved use(s) at the time of approval include: To treat non-small lung cancer.
- Detectnet is a new drug with active ingredient(s) of copper Cu 64 dotatate injection, US FDA approved on 9/3/2020. The FDA approved use(s) at the time of approval include: To help detect certain types of neuroendocrine tumors.
- Sogroya is a new drug with active ingredient(s) of somapacitan-beco, US FDA approved on 8/28/2020. The FDA approved use(s) at the time of approval include: Growth hormone.
- Winlevi is a new drug with active ingredient(s) of clascoterone, US FDA approved on 8/26/2020. The FDA approved use(s) at the time of approval include: To treat acne.
- Enspryng is a new drug with active ingredient(s) of satralizumab-mwge, US FDA approved on 8/14/2020. The FDA approved use(s) at the time of approval include: To treat neuromyelitis optica spectrum disorder.
- Viltepso is a new drug with active ingredient(s) of viltolarsen, US FDA approved on 8/12/2020. The FDA approved use(s) at the time of approval include: To treat Duchenne muscular dystrophy.
- Olinvyk is a new drug with active ingredient(s) of oliceridine, US FDA approved on 8/7/2020. The FDA approved use(s) at the time of approval include: To manage acute pain in certain adults
- Evrysdi is a new drug with active ingredient(s) of risdiplam, US FDA approved on 8/7/2020. The FDA approved use(s) at the time of approval include: To treat spinal muscular atrophy.
- Lampit is a new drug with active ingredient(s) of nifurtimox, US FDA approved on 8/6/2020. The FDA approved use(s) at the time of approval include: To treat Chagas disease in certain pediatric patients younger than age 18
- Blenrep is a new drug with active ingredient(s) of belantamab mafodotin-blmf, US FDA approved on 8/5/2020. The FDA approved use(s) at the time of approval include: To treat multiple myeloma.
- Monjuvi is a new drug with active ingredient(s) of tafasitamab-cxix, US FDA approved on 7/31/2020. The FDA approved use(s) at the time of approval include: To treat relapsed or refractory diffuse large B-cell lymphoma.
- Xeglyze is a new drug with active ingredient(s) of abametapir, US FDA approved on 7/24/2020. The FDA approved use(s) at the time of approval include: To treat head lice.
- Inqovi is a new drug with active ingredient(s) of decitabine, and cedazuridine, US FDA approved on 7/7/2020. The FDA approved use(s) at the time of approval include: To treat adult patients with myelodysplastic syndromes.
- Rukobia is a new drug with active ingredient(s) of fostemsavir, US FDA approved on 7/2/2020. The FDA approved use(s) at the time of approval include: To treat HIV.
- Byfavo is a new drug with active ingredient(s) of remimazolam, US FDA approved on 7/2/2020. The FDA approved use(s) at the time of approval include: For sedation.
- Dojolvi is a new drug with active ingredient(s) of triheptanoin, US FDA approved on 6/30/2020. The FDA approved use(s) at the time of approval include: To treat molecularly long-chain fatty acid oxidation disorders.
- Zepzelca is a new drug with active ingredient(s) of lurbinectedin, US FDA approved on 6/15/2020. The FDA approved use(s) at the time of approval include: To treat metastatic small cell lung cancer.
- Uplizna is a new drug with active ingredient(s) of inebilizumab-cdon, US FDA approved on 6/11/2020. The FDA approved use(s) at the time of approval include: To treat neuromyelitis optica spectrum disorder.
- Tauvid is a new drug with active ingredient(s) of flortaucipir F18, US FDA approved on 5/28/2020. The FDA approved use(s) at the time of approval include: Diagnostic agent for patients with Alzheimer’s disease
- Artesunate is a new drug with active ingredient(s) of artesunate, US FDA approved on 5/26/2020. The FDA approved use(s) at the time of approval include: To treat severe malaria.
- Cerianna is a new drug with active ingredient(s) of fluoroestradiol F18, US FDA approved on 5/20/2020. The FDA approved use(s) at the time of approval include: Diagnostic imaging agent for certain patients with breast cancer.
- Qinlock is a new drug with active ingredient(s) of ripretinib, US FDA approved on 5/15/2020. The FDA approved use(s) at the time of approval include: To treat advanced gastrointestinal-stromal tumors.
- Retevmo is a new drug with active ingredient(s) of selpercatinib, US FDA approved on 5/8/2020. The FDA approved use(s) at the time of approval include: To treat lung, and thyroid cancers.
- Tabrecta is a new drug with active ingredient(s) of capmatinib, US FDA approved on 5/6/2020. The FDA approved use(s) at the time of approval include: To treat patients with non small cell lung cancer.
- Ongentys is a new drug with active ingredient(s) of opicapone, US FDA approved on 4/24/2020. The FDA approved use(s) at the time of approval include: To treat patients with Parkinson’s disease experiencing “off” episodes
- Trodelvy is a new drug with active ingredient(s) of sacituzumab govitecan-hziy, US FDA approved on 4/22/2020. The FDA approved use(s) at the time of approval include: To treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease
- Pemazyre is a new drug with active ingredient(s) of pemigatinib, US FDA approved on 4/17/2020. The FDA approved use(s) at the time of approval include: To treat certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts
- Tukysa is a new drug with active ingredient(s) of tucatinib, US FDA approved on 4/17/2020. The FDA approved use(s) at the time of approval include: To treat advanced unresectable or metastatic HER2-positive breast cancer.
- Koselugo is a new drug with active ingredient(s) of selumetinib, US FDA approved on 4/10/2020. The FDA approved use(s) at the time of approval include: To treat neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves.
- Zeposia is a new drug with active ingredient(s) of ozanimod, US FDA approved on 3/25/2020. The FDA approved use(s) at the time of approval include: To treat relapsing forms of multiple sclerosis.
- Isturisa is a new drug with active ingredient(s) of osilodrostat, US FDA approved on 3/6/2020. The FDA approved use(s) at the time of approval include: To treat adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease
- Sarclisa is a new drug with active ingredient(s) of isatuximab, US FDA approved on 3/2/2020. The FDA approved use(s) at the time of approval include: To treat multiple myeloma.
- Nurtec ODT is a new drug with active ingredient(s) of rimegepant, US FDA approved on 2/27/2020. The FDA approved use(s) at the time of approval include: To treat migraine.
- Barhemsys is a new drug with active ingredient(s) of amisulpride, US FDA approved on 2/26/2020. The FDA approved use(s) at the time of approval include: To help prevent nausea, and [vomiting after surgery
- Vyepti is a new drug with active ingredient(s) of eptinezumab-jjmr, US FDA approved on 2/21/2020. The FDA approved use(s) at the time of approval include: For the preventive treatment of migraine in adults
- Nexletol is a new drug with active ingredient(s) of bempedoic acid, US FDA approved on 2/21/2020. The FDA approved use(s) at the time of approval include: To treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C
- Pizensy is a new drug with active ingredient(s) of lactitol, US FDA approved on 2/12/2020. The FDA approved use(s) at the time of approval include: To treat chronic idiopathic constipation (CIC) in adults.
- Tazverik is a new drug with active ingredient(s) of tazemetostat, US FDA approved on 1/23/2020. The FDA approved use(s) at the time of approval include: To treat epithelioid sarcoma.
- Tepezza is a new drug with active ingredient(s) of teprotumumab-trbw, US FDA approved on 1/21/2020. The FDA approved use(s) at the time of approval include: To treat Thyroid eye disease.
- Ayvakit is a new drug with active ingredient(s) of avapritinib, US FDA approved on 1/9/2020. The FDA approved use(s) at the time of approval include: To treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST).
External links[edit | edit source]
- Novel Drug Approvals for 2021
- Novel Drug Approvals for 2020
- Novel Drug Approvals for 2019
- Novel Drug Approvals for 2018
- Novel Drug Approvals for 2017
- Novel Drug Approvals for 2016
- Novel Drug Approvals for 2015
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