Drug project high-priority medications
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WikiDoc Drug Project — High-Priority Medications
- Template here: Drug page template
- Example here: Clopidogrel
- FDA package insert here: DailyMed
List of high-priority medications
Novel Drug Approvals for 2023
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date |
|---|---|---|---|---|
| 55 | Wainua | eplontersen | 12/21/2023 | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| 54 | Filsuvez | birch triterpenes | 12/18/2023 | To treat wounds associated with dystrophic and junctional epidermolysis bullosa |
| 53 | Fabhalta | iptacopan | 12/5/2023 | To treat paroxysmal nocturnal hemoglobinuria |
| 52 | Ogsiveo | nirogacestat | 11/27/2023 | To treat adults with progressing desmoid tumors who require systemic treatment |
| 51 | Truqap | capivasertib | 11/16/2023 | To treat breast cancer that meets certain disease criteria |
| 50 | Ryzneuta | efbemalenograstim alfa-vuxw | 11/16/2023 | To treat neutropenia |
| 49 | Augtyro | repotrectinib | 11/15/2023 | To treat ROS1-positive non-small cell lung cancer |
| 48 | Defencath | taurolidine, heparin | 11/15/2023 | To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter |
| 47 | Fruzaqla | fruquintinib | 11/08/23 | To treat refractory, metastatic colorectal cancer |
| 46 | Loqtorzi | toripalimab-tpzi | 10/27/2023 | To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies |
| 45 | Omvoh | mirikizumab-mrkz | 10/26/2023 | To treat ulcerative colitis |
| 44 | Agamree | vamorolone | 10/26/2023 | To treat Duchenne muscular dystrophy |
| 43 | Bimzelx | bimekizumab | 10/17/2023 | To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy |
| 42 | Zilbrysq | zilucoplan | 10/17/2023 | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive |
| 41 | Velsipity | etrasimod | 10/12/23 | To treat moderately to severely active ulcerative colitis in adults |
| 40 | Rivfloza | nedosiran | 9/29/2023 | To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function |
| 39 | Pombiliti | cipaglucosidase alfa-atga | 9/28/2023 | To treat late-onset Pompe disease |
| 38 | Exxua | gepirone | 9/22/2023 | To treat major depressive disorder |
| 37 | Ojjaara | momelotinib | 9/15/2023 | To treat intermediate or high-risk myelofibrosis in adults with anemia |
| 36 | Aphexda | motixafortide | 09/08/23 | To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma |
| 35 | Veopoz | pozelimab-bbfg | 8/18/2023 | To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease |
| 34 | Sohonos | palovarotene | 8/16/2023 | To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressiva |
| 33 | Elrexfio | elranatamab-bcmm | 8/14/2023 | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy |
| 32 | Talvey | talquetamab-tgvs | 08/09/23 | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies |
| 31 | Izervay | avacincaptad pegol | 08/04/23 | To treat geographic atrophy secondary to age-related macular degeneration |
| 30 | Zurzuvae | zuranolone | 08/04/23 | To treat postpartum depression |
| 29 | Xdemvy | lotilaner | 7/25/2023 | To treat Demodex blepharitis |
| 28 | Vanflyta | quizartinib | 7/20/2023 | To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria |
| 27 | Beyfortus | nirsevimab-alip | 7/17/2023 | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease |
| 26 | Ngenla | somatrogon-ghla | 6/27/2023 | To treat growth failure due to inadequate secretion of endogenous growth hormone |
| 25 | Rystiggo | rozanolixizumab-noli | 6/26/2023 | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive |
| 24 | Litfulo | ritlecitinib | 6/23/2023 | To treat severely patchy hair loss |
| 23 | Columvi | glofitamab-gxbm | 6/15/2023 | To treat diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy |
| 22 | Inpefa | sotagliflozin | 5/26/2023 | To treat heart failure |
| 21 | Posluma | flotufolastat F 18 | 5/25/2023 | To use with positron emission tomography imaging in certain patients with prostate cancer |
| 20 | Paxlovid | nirmatrelvir, ritonavir | 5/25/2023 | To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 |
| 19 | Xacduro | sulbactam, durlobactam | 5/23/2023 | To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex |
| 18 | Epkinly | epcoritamab-bysp | 5/19/2023 | To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy |
| 17 | Miebo | perfluorhexyloctane | 5/18/2023 | To treat signs and symptoms of dry eye disease |
| 16 | Veozah | fezolinetant | 05/12/23 | To treat moderate to severe hot flashes caused by menopause |
| 15 | Elfabrio | pegunigalsidase alfa-iwxj | 05/09/23 | To treat confirmed Fabry disease |
| 14 | Qalsody | tofersen | 4/25/2023 | To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation |
| 13 | Joenja | leniolisib | 3/24/2023 | To treat activated phosphoinositide 3-kinase delta syndrome |
| 12 | Rezzayo | rezafungin | 3/22/2023 | To treat candidemia and invasive candidiasis |
| 11 | Zynyz | retifanlimab-dlwr | 3/22/2023 | To treat metastatic or recurrent locally advanced Merkel cell carcinoma |
| 10 | Daybue | trofinetide | 03/10/23 | To treat Rett syndrome |
| 9 | Zavzpret | zavegepant | 03/09/23 | To treat migraine |
| 8 | Skyclarys | omaveloxolone | 2/28/2023 | To treat Friedrich’s ataxia |
| 7 | Filspari | sparsentan | 2/17/2023 | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression |
| 6 | Lamzede | velmanase alfa-tycv | 2/16/2023 | To treat non-central nervous system manifestations of alpha-mannosidosis |
| 5 | Jesduvroq | daprodustat | 02/01/23 | To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months |
| 4 | Orserdu | elacestrant | 1/27/2023 | To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy |
| 3 | Jaypirca | pirtobrutinib | 1/27/2023 | To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor |
| 2 | Brenzavvy | bexagliflozin | 1/20/2023 | To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise |
| 1 | Leqembi | lecanemab-irmb | 01/06/23 | To treat Alzheimer’s disease |
Novel Drug Approvals for 2022
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date |
|---|---|---|---|---|
| 37 | NexoBrid | anacaulase-bcdb | 12/28/2022 | To remove eschar in adults with deep partial thickness or full thickness thermal burns |
| 36 | Briumvi | ublituximab-xiiy | 12/28/2022 | To treat relapsing forms of multiple sclerosis |
| 35 | Xenoview | hyperpolarized Xe-129 | 12/23/2022 | To evaluate pulmonary function and imaging |
| 34 | Lunsumio | mosunetuzumab-axgb | 12/22/2022 | To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma |
| 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 considerationsPress Release |
| 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 |
| 31 | Rezlidhia | olutasidenib | 12/1/2022 | To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation |
| 30 | Tzield | teplizumab-mzwv | 11/18/22 | To delay the onset of stage 3 type 1 diabetesPress Release |
| 29 | Elahere | mirvetuximab soravtansine-gynx | 11/14/2022 | To treat patients with recurrent ovarian cancer that is resistant to platinum therapy |
| 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 |
| 27 | Imjudo | tremelimumab | 10/21/2022 | To treat unresectable hepatocellular carcinoma |
| 26 | Lytgobi | futibatinib | 9/30/2022 | To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements |
| 25 | Relyvrio | sodium phenylbutyrate/taurursodiol | 9/29/2022 | To treat amyotrophic lateral sclerosis (ALS)Press Release |
| 24 | Omlonti | oomidenepag isopropyl ophthalmic solution | 9/22/2022 | To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension |
| 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 |
| 22 | Terlivaz | terlipressin | 9/14/2022 | To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function |
| 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 |
| 20 | Sotyktu | deucravacitinib | 9/9/2022 | To treat moderate-to-severe plaque psoriasis |
| 19 | Daxxify | daxibotulinumtoixnA-lanm | 9/7/2022 | To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity |
| 18 | Spevigo | spesolimab-sbzo | 9/1/2022 | To treat generalized pustular psoriasis flares |
| 17 | Xenpozyme | Olipudase alfa | 8/31/2022 | To treat Acid Sphingomyelinase DeficiencyPress Release |
| 16 | Amvuttra | vutrisiran | 6/13/2022 | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| 15 | Vtama | tapinarof | 5/23/2022 | To treat plaque psoriasis |
| 14 | Mounjaro | tirzepatide | 5/13/2022 | To improve blood sugar control in diabetes, in addition to diet and exercise Press Release |
| 13 | Voquezna | vonoprazan, amoxicillin, and clarithromycin | 5/3/2022 | To treat Helicobacter pylori infection |
| 12 | Camzyos | mavacamten | 4/28/2022 | To treat certain classes of obstructive hypertrophic cardiomyopathy |
| 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 |
| 10 | Pluvicto | lutetium (177Lu) vipivotide tetraxetan | 3/23/2022 | To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies |
| 9 | Opdualag | nivolumab and relatlimab-rmbw | 3/18/2022 | To treat unresectable or metastatic melanoma |
| 8 | Ztalmy | ganaxolone | 3/18/2022 | To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder |
| 7 | Vonjo | pacritinib | 2/28/2022 | To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets |
| 6 | Pyrukynd | mitapivat | 2/17/2022 | To treat hemolytic anemia in pyruvate kinase deficiency |
| 5 | Enjaymo | sutimlimab-jome | 2/4/2022 | To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease |
| 4 | Vabysmo | faricimab-svoa | 1/28/2022 | To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema |
| 3 | Kimmtrak | tebentafusp-tebn | 1/25/2022 | To treat unresectable or metastatic uveal melanoma |
| 2 | Cibinqo | abrocitinib | 1/14/2022 | To treat refractory, moderate-to-severe atopic dermatitis |
| 1 | Quviviq | daridorexant | 1/7/2022 | To treat insomnia |
Novel Drug Approvals for 2021
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date |
|---|---|---|---|---|
| 42 | Scemblix | asciminib | 10/29/2021 | To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria |
| 41 | Tavneos | avacopan | 10/7/2021 | To treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy, including glucocorticoids |
| 40 | Livmarli | maralixibat | 9/29/2021 | To treat cholestatic pruritus associated with Alagille syndrome |
| 39 | Qulipta | atogepant | 9/28/2021 | To prevent episodic migraines |
| 38 | Tivdak | tisotumab vedotin-tftv | 9/20/2021 | To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy |
| 37 | Exkivity | mobocertinib | 9/15/2021 | To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations |
| 36 | Skytrofa | lonapegsomatropin-tcgd | 8/25/2021 | To treat short stature due to inadequate secretion of endogenous growth hormone |
| 35 | Korsuva | difelikefalin | 8/23/2021 | To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations |
| 34 | Welireg | belzutifan | 8/13/2021 | To treat von Hippel-Lindau disease under certain conditions |
| 33 | Nexviazyme | avalglucosidase alfa-ngpt | 8/6/2021 | To treat late-onset Pompe disease |
| 32 | Saphnelo | anifrolumab-fnia | 7/30/2021 | To treat moderate-to severe systemic lupus erythematousus along with standard therapy |
| 31 | Bylvay | odevixibat | 7/20/2021 | To treat pruritus |
| 30 | Rezurock | belumosudil | 7/16/2021 | To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy |
| 29 | fexinidazole | fexinidazole | 7/16/2021 | To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense |
| 28 | Kerendia | finerenone | 7/9/2021 | To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes |
| 27 | Rylaze | asparaginase erwinia chrysanthemi (recombinant)-rywn | 6/30/2021 | To treat acute lymphoblastic leukemia and lymphoblastic lymphoma in patients who are allergic to E. coli-derived asparaginase products, as a component of a chemotherapy regimen |
| 26 | Aduhelm | aducanumab-avwa | 6/7/2021 | To treat Alzheimer’s disease |
| 25 | Brexafemme | ibrexafungerp | 6/1/2021 | To treat vulvovaginal candidiasis |
| 24 | Lybalvi | olanzapine and samidorphan | 5/28/2021 | To treat schizophrenia and certain aspects of bipolar I disorder |
| 23 | Truseltiq | infigratinib | 5/28/2021 | To treat cholangiocarcinoma whose disease meets certain criteria |
| 22 | Lumakras | sotorasib | 5/28/2021 | To treat types of non-small cell lung cancer |
| 21 | Pylarify | piflufolastat F 18 | 5/26/2021 | To identify prostate-specific membrane antigen-positive lesions in prostate cancer |
| 20 | Rybrevant | amivantamab-vmjw | 5/21/2021 | To treat a subset of non-small cell lung cancer |
| 19 | Empaveli | pegcetacoplan | 5/14/2021 | To treat paroxysmal nocturnal hemoglobinuria |
| 18 | Zynlonta | loncastuximab tesirine-lpyl | 4/23/2021 | To treat certain types of relapsed or refractory large B-cell lymphoma |
| 17 | Jemperli | dostarlimab-gxly | 4/22/2021 | To treat endometrial cancer |
| 16 | Nextstellis | drospirenone and estetrol | 4/15/2021 | To prevent pregnancy |
| 15 | Qelbree | viloxazine | 4/2/2021 | To treat attention deficit hyperactivity disorder |
| 14 | Zegalogue | dasiglucagon | 3/22/2021 | To treat severe hypoglycemia |
| 13 | Ponvory | ponesimod | 3/18/2021 | To treat relapsing forms of multiple sclerosis |
| 12 | Fotivda | tivozanib | 3/10/2021 | To treat renal cell carcinoma |
| 11 | Azstarys | serdexmethylphenidate and dexmethylphenidate | 3/2/2021 | To treat attention deficit hyperactivity disorder |
| 10 | Pepaxto | melphalan flufenamide | 2/26/2021 | To treat relapsed or refractory multiple myeloma |
| 9 | Nulibry | fosdenopterin | 2/26/2021 | To reduce the risk of mortality in molybdenum cofactor deficiency Type A |
| 8 | Amondys 45 | casimersen | 2/25/2021 | To treat Duchenne muscular dystrophy |
| 7 | Cosela | trilacicilib | 2/12/2021 | To mitigate chemotherapy-induced myelosuppression in small cell lung cancer |
| 6 | Evkeeza | evinacumab-dgnb | 2/11/2021 | To treat homozygous familial hypercholesterolemia |
| 5 | Ukoniq | umbralisib | 2/5/2021 | To treat marginal zone lymphoma and follicular lymphoma |
| 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 (co-packaged) | 1/21/2021 | To treat HIV |
| 1 | Verquvo | vericiguat | 1/19/2021 | To mitigate the risk of cardiovascular death and hospitalization for chronic heart failure |
Novel Drug Approvals for 2020
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date |
|---|---|---|---|---|
| 53 | Gemtesa | vibegron | 12/23/2020 | To treat overactive bladder |
| 52 | Ebanga | ansuvimab-zykl | 12/21/2020 | To treat ebola |
| 51 | Orgovyx | relugolix | 12/18/2020 | To treat advanced prostate cancer |
| 50 | Margenza | margetuximab (anti-HER2 mAb | 12/16/2020 | To treat HER2+ breast cancer |
| 49 | Klisyri | tirbanibulin | 12/14/2020 | To treat actinic Keratosis of the face or scalp |
| 48 | Orladeyo | berotralstat | 12/3/2020 | To treat patients with hereditary angioedema |
| 47 | Gallium 68 PSMA-11 | Gallium 68 PSMA-11 | 12/1/2020 | For detection and localization of prostate cancer |
| 46 | Danyelza | naxitamab-gqgk | 11/25/2020 | To treat high-risk refractory or relapsed neuroblastoma |
| 45 | Imcivree | setmelanotide | 11/25/2020 | 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 |
| 44 | Oxlumo | lumasiran | 11/23/2020 | To treat hyperoxaluria type 1 |
| 43 | Zokinvy | lonafarnib | 11/20/2020 | To treat rare conditions related to premature aging |
| 42 | Veklury | remdesivir | 10/22/2020 | To treat COVID-19 |
| 41 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | 10/14/2020 | To treat ebola virus |
| 40 | Gavreto | pralsetinib | 9/4/2020 | To treat non-small lung cancer |
| 39 | Detectnet | copper Cu 64 dotatate injection | 9/3/2020 | To help detect certain types of neuroendocrine tumors |
| 38 | Sogroya | somapacitan-beco | 8/28/2020 | Growth hormone |
| 37 | Winlevi | clascoterone | 8/26/2020 | To treat acne |
| 36 | Enspryng | satralizumab-mwge | 8/14/2020 | To treat neuromyelitis optica spectrum disorder |
| 35 | Viltepso | viltolarsen | 8/12/2020 | To treat Duchenne muscular dystrophy |
| 34 | Olinvyk | oliceridine | 8/7/2020 | To manage acute pain in certain adults |
| 33 | Evrysdi | risdiplam | 8/7/2020 | To treat spinal muscular atrophy |
| 32 | Lampit | nifurtimox | 8/6/2020 | To treat Chagas disease in certain pediatric patients younger than age 18 |
| 31 | Blenrep | belantamab mafodotin-blmf | 8/5/2020 | To treat multiple myeloma |
| 30 | Monjuvi | tafasitamab-cxix | 7/31/2020 | To treat relapsed or refractory diffuse large B-cell lymphoma |
| 29 | Xeglyze | abametapir | 7/24/2020 | To treat head lice |
| 28 | Inqovi | decitabine and cedazuridine | 7/7/2020 | To treat adult patients with myelodysplastic syndromes |
| 27 | Rukobia | fostemsavir | 7/2/2020 | To treat HIV |
| 26 | Byfavo | remimazolam | 7/2/2020 | For sedation |
| 25 | Dojolvi | triheptanoin | 6/30/2020 | To treat molecularly long-chain fatty acid oxidation disorders |
| 24 | Zepzelca | lurbinectedin | 6/15/2020 | To treat metastatic small cell lung cancer |
| 23 | Uplizna | inebilizumab-cdon | 6/11/2020 | To treat neuromyelitis optica spectrum disorder |
| 22 | Tauvid | flortaucipir F18 | 5/28/2020 | Diagnostic agent for patients with Alzheimer’s disease |
| 21 | Artesunate | artesunate | 5/26/2020 | To treat severe malaria |
| 20 | Cerianna | fluoroestradiol F18 | 5/20/2020 | Diagnostic imaging agent for certain patients with breast cancer |
| 19 | Qinlock | ripretinib | 5/15/2020 | To treat advanced gastrointestinal-stromal tumors |
| 18 | Retevmo | selpercatinib | 5/8/2020 | To treat lung and thyroid cancers |
| 17 | Tabrecta | capmatinib | 5/6/2020 | To treat patients with non small cell lung cancer |
| 16 | Ongentys | opicapone | 4/24/2020 | To treat patients with Parkinson’s disease experiencing “off” episodes |
| 15 | Trodelvy | sacituzumab govitecan-hziy | 4/22/2020 | To treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease |
| 14 | Pemazyre | pemigatinib | 4/17/2020 | To treat certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts |
| 13 | Tukysa | tucatinib | 4/17/2020 | To treat advanced unresectable or metastatic HER2-positive breast cancer |
| 12 | Koselugo | selumetinib | 4/10/2020 | To treat neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves |
| 11 | Zeposia | ozanimod | 3/25/2020 | To treat relapsing forms of multiple sclerosis |
| 10 | Isturisa | osilodrostat | 3/6/2020 | To treat adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease |
| 9 | Sarclisa | isatuximab | 3/2/2020 | To treat multiple myloma |
| 8 | Nurtec ODT | rimegepant | 2/27/2020 | To treat migraine |
| 7 | Barhemsys | amisulpride | 2/26/2020 | To help prevent nausea and vomiting after surgery |
| 6 | Vyepti | eptinezumab-jjmr | 2/21/2020 | For the preventive treatment of migraine in adults |
| 5 | Nexletol | bempedoic acid | 2/21/2020 | To treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C |
| 4 | Pizensy | lactitol | 2/12/2020 | To treat chronic idiopathic constipation (CIC) in adults |
| 3 | Tazverik | tazemetostat | 1/23/2020 | To treat epithelioid sarcoma |
| 2 | Tepezza | teprotumumab-trbw | 1/21/2020 | To treat Thyroid eye disease |
| 1 | Ayvakit | avapritinib | 1/9/2020 | To treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) |
Novel Drug Approvals for 2019
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date |
|---|---|---|---|---|
| 48 | Ubrelvy | ubrogepant | 12/23/2019 | to treat acute treatment of migraine with or without aura in adults |
| 47 | Enhertu | fam-trastuzumab deruxtecan-nxki | 12/20/2019 | To treat metastatic breast cancer |
| 46 | Dayvigo | lemborexant | 12/20/2019 | To treat insomnia |
| 45 | Caplyta | lumateperone tosylate | 12/20/2019 | To treat schizophrenia |
| 44 | TissueBlue | Brilliant Blue G Ophthalmic Solution | 12/20/2019 | Dye used in eye surgery |
| 43 | Padcev | enfortumab vedotin-ejfv | 12/18/2019 | To treat refractory bladder cancer |
| 42 | Vyondys 53 | golodirsen | 12/12/2019 | To treat certain patients with Duchenne muscular dystrophy |
| 41 | Oxbryta | voxelotor | 11/25/2019 | To treat sickle cell disease |
| 40 | Xcopri | cenobamate | 11/21/2019 | To treat partial onset seizures |
| 39 | Givlaari | givosiran | 11/20/2019 | To treat acute hepatic porphyria, a rare blood disorder |
| 38 | Adakveo | crizanlizumab-tmca | 11/15/2019 | To treat patients with painful complication of sickle cell disease |
| 37 | Fetroja | cefiderocol | 11/14/2019 | To treat patients with complicated urinary tract infections who have limited or no alternative treatment options |
| 36 | Brukinsa | zanubrutinib | 11/14/2019 | To treat certain patients with mantle cell lymphoma, a form of blood cancer |
| 35 | Reblozyl | luspatercept–aamt | 11/8/2019 | For the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions |
| 34 | ExEm Foam | air polymer-type A | 11/7/2019 | A diagnostic agent used to assess fallopian tube patency (openness) in women with known or suspected infertility |
| 33 | Trikafta | elexacaftor/ivacaftor/tezacaftor | 10/21/2019 | To treat patients 12 years of age and older with the most common gene mutation that causes cystic fibrosis |
| 32 | Reyvow | lasmiditan | 10/11/2019 | For the acute treatment of migraine with or without aura, in adults |
| 31 | fluorodopa F 18 | 10/10/2019 | A diagnostic agent for use in positron emission tomography (PET) to help diagnose adult patients with suspected Parkinsonian syndromes (PS) | |
| 30 | Scenesse | afamelanotide | 10/8/2019 | To increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria |
| 29 | Beovu | brolucizumab–dbll | 10/7/2019 | Treatment of wet age-related macular degeneration |
| 28 | Aklief | trifarotene | 10/4/2019 | For the topical treatment of acne vulgaris in patients 9 years of age and older |
| 27 | Ibsrela | tenapanor | 9/12/2019 | To treat irritable bowel syndrome with constipation in adults. |
| 26 | Nourianz | istradefylline | 8/27/2019 | To treat adult patients with Parkinson’s disease experiencing “off” episodes |
| 25 | Ga-68-DOTATOC | Ga-68-DOTATOC | 8/21/2019 | For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) |
| 24 | Xenleta | lefamulin | 8/19/2019 | To treat adults with community-acquired bacterial pneumonia |
| 23 | Rinvoq | upadacitinib | 8/16/2019 | To treat adults with moderately to severely active rheumatoid arthritis |
| 22 | Inrebic | fedratinib | 8/16/2019 | To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis |
| 21 | Rozlytrek | entrectinib | 8/15/2019 | To treat adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive |
| 20 | Wakix | pitolisant | 8/14/2019 | To treat excessive daytime sleepiness (EDS) in adult patients with narcolepsy |
| 19 | pretomanid | 8/14/2019 | For treatment-resistant forms of tuberculosis that affects the lungs | |
| 18 | Turalio | pexidartinib | 8/2/2019 | To treat adult patients with symptomatic tenosynovial giant cell tumor |
| 17 | Nubeqa | darolutamide | 7/30/2019 | To treat adult patients with non-metastatic castration resistant prostate cancer |
| 16 | Accrufer | ferric maltol | 7/25/2019 | To treat iron deficiency anemia in adults |
| 15 | Recarbrio | imipenem, cilastatin and relebactam | 7/16/2019 | To treat complicated urinary tract and complicated intra-abdominal infections |
| 14 | Xpovio | selinexor | 7/3/2019 | To treat adult patients with relapsed or refractory multiple myeloma (RRMM) |
| 13 | Vyleesi | bremelanotide | 6/21/2018 | To treat hypoactive sexual desire disorder in premenopausal women. |
| 12 | Polivy | polatuzumab vedotin-piiq | 6/10/2019 | To treat adult patients with relapsed or refractory diffuse large B-cell lymphoma |
| 11 | Piqray | alpelisib | 5/24/2019 | To treat breast cancer |
| 10 | Vyndaqel | tafamidis meglumine | 5/3/2019 | To treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults |
| 9 | Skyrizi | risankizumab-rzaa | 4/23/2019 | To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy |
| 8 | Balversa | erdafitinib | 4/12/2019 | To treat adult patients with locally advanced or metastatic bladder cancer |
| 7 | Evenity | romosozumab-aqqg | 4/9/2019 | To treat osteoporosis in postmenopausal women at high risk of fracture |
| 6 | Mayzent | siponimod | 3/26/2019 | To treat adults with relapsing forms of multiple sclerosis |
| 5 | Sunosi | solriamfetol | 3/20/2019 | To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea |
| 4 | Zulresso | brexanolone | 3/19/2019 | To treat postpartum depression (PPD) in adult women |
| 3 | Egaten | triclabendazole | 2/13/2019 | To treat fascioliasis, a parasitic infestation caused by two species of flatworms or trematodes that mainly the affect the liver, sometimes referred to as “liver flukes” |
| 2 | Cablivi | caplacizumab-yhdp | 2/6/2019 | To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) |
| 1 | Jeuveau | prabotulinumtoxinA-xvfs | 2/1/2019 | For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients |