Health Dictionary
Reliable, easy-to-read patient information on common medical conditions — written in plain language, free of jargon, and grounded in current evidence. Browse the most frequent diagnoses, understand what they mean for everyday life, and learn which steps and questions help you have a focused conversation with your doctor.
Drug project high-priority medications
Introduction
   Mission Statement  Â
   Tutorial  Â
   Editor’s Checklist  Â
   List of Medications  Â
   High-Priority Medications  Â
WikiDoc Drug Project — High-Priority Medications
WikiDoc Drug Project — High-Priority Medications
- Template here: Drug page template
- Example here: Clopidogrel
- FDA package insert here: DailyMed
List of high-priority medications
List of high-priority medications
Novel Drug Approvals for 2024
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date |
|---|---|---|---|---|
| 50 | Alhemo | concizumab-mtci | 12/20/2024 | For routine prophylaxis to prevent bleeding episodes in hemophilia A and B |
| 49 | Alyftrek | vanzacaftor, tezacaftor, and deutivacaftor | 12/20/2024 | To treat cystic fibrosis |
| 48 | Tryngolza | olezarsen | 12/19/2024 | To treat familial chylomicronemia syndrome |
| 47 | Ensacove | ensartinib | 12/18/2024 | To treat non-small cell lung cancer |
| 46 | Crenessity | crinecerfont | 12/13/2024 | To treat classic congenital adrenal hyperplasia |
| 45 | Unloxcyt | cosibelimab-ipdl | 12/13/2024 | To treat cutaneous squamous cell carcinoma |
| 44 | Bizengri | zenocutuzumab-zbco | 12/4/2024 | To treat non-small cell lung cancer and pancreatic adenocarcinoma |
| 43 | Iomervu | iomeprol | 11/27/2024 | For use as a radiographic contrast agent |
| 42 | Rapiblyk | landiolol | 11/22/2024 | To treat supraventricular tachycardia |
| 41 | Attruby | acoramidis | 11/22/2024 | To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis |
| 40 | Ziihera | zanidatamab-hrii | 11/20/2024 | To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer |
| 39 | Revuforj | revumenib | 11/15/2024 | To treat relapsed or refractory acute leukemia |
| 38 | Orlynvah | sulopenem etzadroxil, probenecid | 10/25/2024 | To treat uncomplicated urinary tract infections (uUTI) |
| 37 | Vyloy | zolbetuximab-clzb | 10/18/2024 | To treat gastric or gastroesophageal junction adenocarcinoma |
| 36 | Hympavzi | marstacimab-hncq | 10/11/2024 | To prevent or reduce bleeding episodes related to hemophilia A or B |
| 35 | Itovebi | inavolisib | 10/10/2024 | To treat locally advanced or metastatic breast cancer |
| 34 | Flyrcado | flurpiridaz F 18 | 9/27/2024 | A radioactive diagnostic drug to evaluate for myocardial ischemia and infarction |
| 33 | Cobenfy | xanomeline and trospium chloride | 9/26/2024 | To treat schizophrenia |
| 32 | Aqneursa | levacetylleucine | 9/24/2024 | To treat Niemann-Pick disease type C |
| 31 | Miplyffa | arimoclomol | 9/20/2024 | To treat Niemann-Pick disease type C |
| 30 | Ebglyss | lebrikizumab-lbkz | 9/13/2024 | To treat moderate-to-severe atopic dermatitis |
| 29 | Lazcluze | Lazertinib | 8/19/2024 | To treat non-small cell lung cancer |
| 28 | Niktimvo | axatilimab-csfr | 8/14/2024 | To treat chronic graft-versus-host disease (cGVHD) |
| 27 | Livdelzi | seladelpar | 8/14/2024 | To treat primary biliary cholangitis (PBC) |
| 26 | Nemluvio | nemolizumab-ilto | 8/12/2024 | To treat prurigo nodularis |
| 25 | Yorvipath | palopegteriparatide | 8/9/2024 | To treat hypoparathyroidism |
| 24 | Voranigo | vorasidenib | 8/6/2024 | To treat Grade 2 astrocytoma or oligodendroglioma |
| 23 | Leqselvi | deuruxolitinib | 7/25/2024 | To treat severe alopecia areata |
| 22 | Kisunla | donanemab-azbt | 7/2/2024 | To treat Alzheimer’s disease |
| 21 | Ohtuvayre | ensifentrine | 6/26/2024 | To treat chronic obstructive pulmonary disease |
| 20 | Piasky | crovalimab-akkz | 6/20/2024 | To treat paroxysmal nocturnal hemoglobinuria |
| 19 | Sofdra | sofpironium | 6/18/2024 | To treat primary axillary hyperhidrosis |
| 18 | Iqirvo | elafibranor | 6/10/2024 | To treat primary biliary cholangitis in combination with ursodeoxycholic acid |
| 17 | Rytelo | imetelstat | 6/6/2024 | To treat low- to intermediate-1 risk myelodysplastic syndromes |
| 16 | Imdelltra | tarlatamab-dlle | 5/16/2024 | To treat extensive stage small cell lung cancer |
| 15 | Xolremdi | mavorixafor | 4/26/2024 | To treat WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) |
| 14 | Ojemda | tovorafenib | 4/23/2024 | To treat relapsed or refractory pediatric low-grade glioma |
| 13 | Anktiva | nogapendekin alfa inbakicept-pmln | 4/22/2024 | To treat bladder cancer |
| 12 | Lumisight | pegulicianine | 4/17/2024 | To use as an optical imaging agent for the detection of cancerous tissue |
| 11 | Zevtera | ceftobiprole medocaril sodium | 4/3/2024 | To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia |
| 10 | Voydeya | danicopan | 3/29/2024 | To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria |
| 9 | Vafseo | vadadustat | 3/27/2024 | To treat anemia due to chronic kidney disease |
| 8 | Winrevair | sotatercept-csrk | 3/26/2024 | To treat pulmonary arterial hypertension |
| 7 | Duvyzat | givinostat | 3/21/2024 | To treat Duchenne muscular dystrophy in individuals aged 6 years and older |
| 6 | Tryvio | aprocitentan | 3/19/2024 | To treat hypertension |
| 5 | Rezdiffra | resmetirom | 3/14/2024 | To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring |
| 4 | Tevimbra | tislelizumab-jsgr | 3/13/2024 | To treat unresectable or metastatic esophageal squamous cell carcinoma |
| 3 | Letybo | letibotulinumtoxinA-wlbg | 2/29/2024 | To temporarily improve the appearance of moderate-to-severe glabellar lines |
| 2 | Exblifep | cefepime, enmetazobactam | 2/22/2024 | To treat complicated urinary tract infections |
| 1 | Zelsuvmi | berdazimer | 1/5/2024 | To treat molluscum contagiosum |
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 |