Novel Drug Approvals for 2020
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10 Jan 2021
1 . Gemtesa
Approval Date : 2020-12-23
Active Ingredient: vibegron
Indication : To treat overactive bladder
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2 . Ebanga
Approval Date : 2020-12-21
Active Ingredient: ansuvimab-zykl
Indication : To treat ebola
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3 . Orgovyx
Approval Date : 2020-12-18
Active Ingredient: relugolix
Indication : To treat advanced prostate cancer
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4 . Margenza
Approval Date : 2020-12-16
Active Ingredient: margetuximab (anti-HER2 mAb
Indication : To treat HER2+ breast cancer
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5 . Klisyri
Approval Date : 2020-12-14
Active Ingredient: tirbanibulin
Indication : To treat actinic Keratosis of the face or scalp
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6 . Orladeyo
Approval Date : 2020-12-03
Active Ingredient: berotralstat
Indication : To treat patients with hereditary angioedema
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7 . Gallium 68 PSMA-11
Approval Date : 2020-12-01
Active Ingredient: Gallium 68 PSMA-11
Indication : For detection and localization of prostate cancer
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8 . Danyelza
Approval Date : 2020-11-25
Active Ingredient: naxitamab-gqgk
Indication : To treat high-risk refractory or relapsed neuroblastoma
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9 . Imcivree
Approval Date : 2020-11-25
Active Ingredient: setmelanotide
Indication : 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
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10 . Oxlumo
Approval Date : 2020-11-23
Active Ingredient: lumasiran
Indication : To treat hyperoxaluria type 1
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11 . Zokinvy
Approval Date : 2020-11-20
Active Ingredient: lonafarnib
Indication : To treat rare conditions related to premature aging
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12 . Veklury
Approval Date : 2020-10-22
Active Ingredient: remdesivir
Indication : To treat COVID-19
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13 . Inmazeb
Approval Date : 2020-10-14
Active Ingredient: atoltivimab, maftivimab, and odesivimab-ebgn
Indication : To treat ebola virus
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14 . Gavreto
Approval Date : 2020-09-04
Active Ingredient: pralsetinib
Indication : To treat non-small lung cancer
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15 . Detectnet
Approval Date : 2020-09-03
Active Ingredient: copper Cu 64 dotatate injection
Indication : To help detect certain types of neuroendocrine tumors
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16 . Sogroya
Approval Date : 2020-08-28
Active Ingredient: somapacitan-beco
Indication : Growth hormone
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17 . Winlevi
Approval Date : 2020-08-26
Active Ingredient: clascoterone
Indication : To treat acne
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18 . Enspryng
Approval Date : 2020-08-14
Active Ingredient: satralizumab-mwge
Indication : To treat neuromyelitis optica spectrum disorder
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19 . Viltepso
Approval Date : 2020-08-12
Active Ingredient: viltolarsen
Indication : To treat Duchenne muscular dystrophy
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20 . Olinvyk
Approval Date : 2020-08-07
Active Ingredient: oliceridine
Indication : To manage acute pain in certain adults
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21 . Evrysdi
Approval Date : 2020-08-07
Active Ingredient: risdiplam
Indication : To treat spinal muscular atrophy
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22 . Lampit
Approval Date : 2020-08-06
Active Ingredient: nifurtimox
Indication : To treat Chagas disease in certain pediatric patients younger than age 18
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23 . Blenrep
Approval Date : 2020-08-05
Active Ingredient: belantamab mafodotin-blmf
Indication : To treat multiple myeloma
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24 . Monjuvi
Approval Date : 2020-07-31
Active Ingredient: tafasitamab-cxix
Indication : To treat relapsed or refractory diffuse large B-cell lymphoma
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25 . Xeglyze
Approval Date : 2020-07-24
Active Ingredient: abametapir
Indication : To treat head lice
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26 . Inqovi
Approval Date : 2020-07-07
Active Ingredient: decitabine and cedazuridine
Indication : To treat adult patients with myelodysplastic syndromes
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27 . Rukobia
Approval Date : 2020-07-02
Active Ingredient: fostemsavir
Indication : To treat HIV
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28 . Byfavo
Approval Date : 2020-07-02
Active Ingredient: remimazolam
Indication : For sedation
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29 . Dojolvi
Approval Date : 2020-06-30
Active Ingredient: triheptanoin
Indication : To treat molecularly long-chain fatty acid oxidation disorders
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30 . Zepzelca
Approval Date : 2020-06-15
Active Ingredient: lurbinectedin
Indication : To treat metastatic small cell lung cancer
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31 . Uplizna
Approval Date : 2020-06-11
Active Ingredient: inebilizumab-cdon
Indication : To treat neuromyelitis optica spectrum disorder
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32 . Tauvid
Approval Date : 2020-05-28
Active Ingredient: flortaucipir F18
Indication : Diagnostic agent for patients with Alzheimer’s disease
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33 . Artesunate
Approval Date : 2020-05-26
Active Ingredient: artesunate
Indication : To treat severe malaria
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34 . Cerianna
Approval Date : 2020-05-20
Active Ingredient: fluoroestradiol F18
Indication : Diagnostic imaging agent for certain patients with breast cancer
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35 . Qinlock
Approval Date : 2020-05-15
Active Ingredient: ripretinib
Indication : To treat advanced gastrointestinal-stromal tumors
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36 . Retevmo
Approval Date : 2020-05-08
Active Ingredient: selpercatinib
Indication : To treat lung and thyroid cancers
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37 . Tabrecta
Approval Date : 2020-05-06
Active Ingredient: capmatinib
Indication : To treat patients with non small cell lung cancer
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38 . Ongentys
Approval Date : 2020-04-24
Active Ingredient: opicapone
Indication : To treat patients with Parkinson’s disease experiencing “off” episodes
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39 . Trodelvy
Approval Date : 2020-04-22
Active Ingredient: sacituzumab govitecan-hziy
Indication : To treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease
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40 . Pemazyre
Approval Date : 2020-04-17
Active Ingredient: pemigatinib
Indication : To treat certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts
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41 . Tukysa
Approval Date : 2020-04-17
Active Ingredient: tucatinib
Indication : To treat advanced unresectable or metastatic HER2-positive breast cancer
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42 . Koselugo
Approval Date : 2020-04-10
Active Ingredient: selumetinib
Indication : To treat neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves
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43 . Zeposia
Approval Date : 2020-03-25
Active Ingredient: ozanimod
Indication : To treat relapsing forms of multiple sclerosis
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44 . Isturisa
Approval Date : 2020-03-06
Active Ingredient: osilodrostat
Indication : To treat adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease
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45 . Sarclisa
Approval Date : 2020-03-02
Active Ingredient: isatuximab
Indication : To treat multiple myloma
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46 . Nurtec ODT
Approval Date : 2020-02-27
Active Ingredient: rimegepant
Indication : To treat migraine
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47 . Barhemsys
Approval Date : 2020-02-26
Active Ingredient: amisulpride
Indication : To help prevent nausea and vomiting after surgery
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48 . Vyepti
Approval Date : 2020-02-21
Active Ingredient: eptinezumab-jjmr
Indication : For the preventive treatment of migraine in adults
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49 . Nexletol
Approval Date : 2020-02-21
Active Ingredient: bempedoic acid
Indication : To treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C
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50 . Pizensy
Approval Date : 2020-02-12
Active Ingredient: lactitol
Indication : To treat chronic idiopathic constipation (CIC) in adults
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51 . Tazverik
Approval Date : 2020-01-23
Active Ingredient: tazemetostat
Indication : To treat epithelioid sarcoma
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52 . Tepezza
Approval Date : 2020-01-21
Active Ingredient: teprotumumab-trbw
Indication : To treat Thyroid eye disease
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53 . Ayvakit
Approval Date : 2020-01-09
Active Ingredient: avapritinib
Indication : To treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST)
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