New drug approvals

Here is a list of the new drug approvals as approved by the US Food and Drug Administration.

Drug Research

New drug approvals for 2021

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 Press Release
1.	Verquvo	vericiguat	1/19/2021	To treat chronic heart failure

New drug approvals 2020

• 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

• 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