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Novel Drug Approvals for 2020

10 January 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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