The table below provides data on FDA new drug therapies approval from 2015 to present. Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drugs and biological products. This table will be updated regularly and is sourced from the FDA portal.
| Drug Name | Active Ingredient | Approval Date | Approval Year | FDA-approved use on approval date* |
|---|---|---|---|---|
| Cytalux | Pafolacianine | 11/29/2021 | 2021 | Identify ovarian cancer lesions |
| Livtencity | Maribavir | 11/23/2021 | 2021 | Post-transplant cytomegalovirus (CMV) infection/disease |
| Voxzogo | Vosoritide | 11/19/2021 | 2021 | Improve growth in children five years of age and older with achondroplasia and open epiphyses |
| Besremi | Ropeginterferon alfa-2b-njft | 11/12/2021 | 2021 | Polycythemia vera |
| Scemblix | Asciminib | 10/29/2021 | 2021 | Philadelphia chromosome-positive chronic myeloid leukemia |
| Tavneos | Avacopan | 10/7/2021 | 2021 | Severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis |
| Livmarli | Maralixibat | 9/29/2021 | 2021 | Cholestatic pruritus associated with Alagille syndrome |
| Qulipta | Atogepant | 9/28/2021 | 2021 | Episodic migraine prevention |
| Tivdak | Tisotumab Vedotin-Tftv | 9/20/2021 | 2021 | Recurrent or metastatic cervical cancer with disease progression on or after chemotherapy |
| Exkivity | Mobocertinib | 9/15/2021 | 2021 | Locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations |
| Skytrofa | Lonapegsomatropin-Tcgd | 8/25/2021 | 2021 | Short stature due to inadequate secretion of endogenous growth hormone |
| Korsuva | Difelikefalin | 8/23/2021 | 2021 | Moderate-to-severe pruritus associated with chronic kidney disease |
| Welireg | Belzutifan | 8/13/2021 | 2021 | Von Hippel-Lindau disease |
| Nexviazyme | avalglucosidase alfa-ngpt | 8/6/2021 | 2021 | Late-onset Pompe disease |
| Saphnelo | anifrolumab-fnia | 7/30/2021 | 2021 | Moderate-to severe systemic lupus erythematousus along with standard therapy |
| Bylvay | odevixibat | 7/20/2021 | 2021 | Pruritus |
| Rezurock | belumosudil | 7/16/2021 | 2021 | Chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy |
| fexinidazole | fexinidazole | 7/16/2021 | 2021 | Human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense |
| Kerendia | finerenone | 7/9/2021 | 2021 | Risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes |
| Rylaze | asparaginase erwinia chrysanthemi (recombinant)-rywn | 6/30/2021 | 2021 | Acute lymphoblastic leukemia and lymphoblastic lymphoma in patients who are allergic to E. coli-derived asparaginase products |
| Aduhelm | Aducanumab | 6/7/2021 | 2021 | Alzheimer’s disease |
| Brexafemme | Ibrexafungerp tablets | 6/1/2021 | 2021 | Vulvovaginal candidiasis in adult females and pediatric females who have begun menstruating |
| Lybalvi | Olanzapine/samidorphan | 5/28/2021 | 2021 | Schizophrenia in adults and certain aspects of bipolar I disorder in adults |
| Truseltiq | Infigratinib | 5/28/2021 | 2021 | Cholangiocarcinoma whose disease meets certain criteria |
| Lumakras | Sotorasib | 5/28/2021 | 2021 | Non-small cell lung cancer whose disease meets certain criteria |
| Pylarify | Piflufolastat F 18 injection | 5/26/2021 | 2021 | Positron emission tomography imaging of prostate-specific membrane antigen-positive lesions in men with prostate cancer |
| Rybrevant | Amivantamab-vmjw | 5/21/2021 | 2021 | Subset of non-small cell lung cancer |
| Empaveli | Pegcetacoplan | 5/14/2021 | 2021 | Paroxysmal nocturnal hemoglobinuria (PNH) |
| Zynlonta | loncastuximab tesirine-lpyl | 4/23/2021 | 2021 | Certain types of relapsed or refractory large B-cell lymphoma |
| Jemperli | Dostarlimab-gxly | 4/22/2021 | 2021 | Endometrial cancer |
| Nextstellis | Drospirenone and estetrol tablets | 4/15/2021 | 2021 | Prevent pregnancy |
| Qelbree | Viloxazine | 4/2/2021 | 2021 | Attention deficit hyperactivity disorder |
| Zegalogue | Dasiglucagon | 3/22/2021 | 2021 | Severe hypoglycemia |
| Ponvory | Ponesimod | 3/18/2021 | 2021 | Relapsing forms of multiple sclerosis |
| Fotivda | Tivozanib | 3/10/2021 | 2021 | Renal cell carcinoma |
| Azstarys | Serdexmethylphenidate and dexmethylphenidate | 3/3/2021 | 2021 | Attention Deficit Hyperactivity |
| Pepaxto | Melphalan flufenamide | 2/26/2021 | 2021 | Relapsed or refractory multiple myeloma |
| Nulibry | Fosdenopterin | 2/26/2021 | 2021 | Molybdenum cofactor deficiency Type A |
| Amondys 45 | Casimersen | 2/25/2021 | 2021 | Duchenne muscular dystrophy |
| Cosela | Trilacicilib | 2/12/2021 | 2021 | Mitigate chemotherapy-induced myelosuppression in adult patients with small cell lung cance |
| Evkeeza | Evinacumab-dgnb | 2/11/2021 | 2021 | Homozygous familial hypercholesterolemia |
| Ukoniq | Umbralisib | 2/5/2021 | 2021 | Marginal zone lymphoma and follicular lymphoma |
| Tepmetko | Tepotinib | 2/3/2021 | 2021 | Non-small cell lung cancer |
| Lupkynis | Voclosporin | 1/22/2021 | 2021 | Lupus nephritis |
| Cabenuva | Cabotegravir and rilpivirine | 1/21/2021 | 2021 | Treatment regimen for HIV-1 infection in treatment-naïve adult patients |
| Vocabria | Cabotegravir | 1/21/2021 | 2021 | Treatment regiment for HIV-1 infection in treatment-naïve adult patients |
| Verquvo | Verciguat | 1/19/2021 | 2021 | Chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics |
| Xalkori | Crizotinib | 1/14/2020 | 2021 | Pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase positive |
| Gemtesa | Vibegron | 12/23/2020 | 2020 | Overactive bladder |
| Ebanga | Ansuvimab-zykl | 12/21/2020 | 2020 | Ebola |
| Orgovyx | Relugolix | 12/18/2020 | 2020 | Advanced prostate cancer |
| Margenza | Margetuximab (anti-HER2 mAb | 12/16/2020 | 2020 | HER2+ breast cancer |
| Klisyri | Tirbanibulin | 12/14/2020 | 2020 | Actinic Keratosis of the face or scalp |
| Orladeyo | Berotralstat | 12/3/2020 | 2020 | To treat patients with hereditary angioedema |
| Gallium 68 PSMA-11 | Gallium 68 PSMA-11 | 12/1/2020 | 2020 | For detection and localization of prostate cancer |
| Danyelza | Naxitamab-gqgk | 11/25/2020 | 2020 | High-risk refractory or relapsed neuroblastoma |
| Imcivree | Setmelanotide | 11/25/2020 | 2020 | Obesity and the control of hunger associated with pro-opiomelanocortin deficiency |
| Oxlumo | Lumasiran | 11/23/2020 | 2020 | Hyperoxaluria type 1 |
| Zokinvy | Lonafarnib | 11/20/2020 | 2020 | To treat rare conditions related to premature aging |
| Veklury | Remdesivir | 10/22/2020 | 2020 | COVID-19 |
| Inmazeb | Atoltivimab, maftivimab, and odesivimab-ebgn | 10/14/2020 | 2020 | Ebola virus |
| Gavreto | Pralsetinib | 9/4/2020 | 2020 | Non-small lung cancer |
| Detectnet | Copper Cu 64 dotatate injection | 9/3/2020 | 2020 | To help detect certain types of neuroendocrine tumors |
| Sogroya | Somapacitan-beco | 8/28/2020 | 2020 | Growth hormone |
| Winlevi | Clascoterone | 8/26/2020 | 2020 | Acne |
| Enspryng | Satralizumab-mwge | 8/14/2020 | 2020 | Neuromyelitis optica spectrum disorder |
| Viltepso | Viltolarsen | 8/12/2020 | 2020 | Duchenne muscular dystrophy |
| Olinvyk | Oliceridine | 8/7/2020 | 2020 | To manage acute pain in certain adults |
| Evrysdi | Risdiplam | 8/7/2020 | 2020 | Spinal muscular atrophy |
| Lampit | Nifurtimox | 8/6/2020 | 2020 | Chagas disease in certain pediatric patients younger than age 18 |
| Blenrep | Belantamab mafodotin-blmf | 8/5/2020 | 2020 | Multiple myeloma |
| Monjuvi | Tafasitamab-cxix | 7/31/2020 | 2020 | Relapsed or refractory diffuse large B-cell lymphoma |
| Xeglyze | Abametapir | 7/24/2020 | 2020 | Head lice |
| Inqovi | Decitabine and cedazuridine | 7/7/2020 | 2020 | Adult patients with myelodysplastic syndromes |
| Rukobia | Fostemsavir | 7/2/2020 | 2020 | HIV |
| Byfavo | Remimazolam | 7/2/2020 | 2020 | For sedation |
| Dojolvi | Triheptanoin | 6/30/2020 | 2020 | Molecularly long-chain fatty acid oxidation disorders |
| Zepzelca | Lurbinectedin | 6/15/2020 | 2020 | Metastatic small cell lung cancer |
| Uplizna | Inebilizumab-cdon | 6/11/2020 | 2020 | Neuromyelitis optica spectrum disorder |
| Tauvid | Flortaucipir F18 | 5/28/2020 | 2020 | Diagnostic agent for patients with Alzheimer’s disease |
| Artesunate | Artesunate | 5/26/2020 | 2020 | Severe malaria |
| Cerianna | Fluoroestradiol F18 | 5/20/2020 | 2020 | Diagnostic imaging agent for certain patients with breast cancer |
| Qinlock | Ripretinib | 5/15/2020 | 2020 | Advanced gastrointestinal-stromal tumors |
| Retevmo | Selpercatinib | 5/8/2020 | 2020 | Lung and thyroid cancers |
| Tabrecta | Capmatinib | 5/6/2020 | 2020 | Patients with non small cell lung cancer |
| Ongentys | Opicapone | 4/24/2020 | 2020 | To treat patients with Parkinson’s disease experiencing “off” episodes |
| Trodelvy | Sacituzumab govitecan-hziy | 4/22/2020 | 2020 | Adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease |
| Pemazyre | Pemigatinib | 4/17/2020 | 2020 | Certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts |
| Tukysa | Tucatinib | 4/17/2020 | 2020 | Advanced unresectable or metastatic HER2-positive breast cancer |
| Koselugo | Selumetinib | 4/10/2020 | 2020 | Neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves |
| Zeposia | Ozanimod | 3/25/2020 | 2020 | Relapsing forms of multiple sclerosis |
| Isturisa | Osilodrostat | 3/6/2020 | 2020 | Adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease |
| Sarclisa | Isatuximab | 3/2/2020 | 2020 | Multiple myloma |
| Nurtec ODT | Rimegepant | 2/27/2020 | 2020 | Migraine |
| Barhemsys | Amisulpride | 2/26/2020 | 2020 | To help prevent nausea and vomiting after surgery |
| Vyepti | Eptinezumab-jjmr | 2/21/2020 | 2020 | For the preventive treatment of migraine in adults |
| Nexletol | Bempedoic acid | 2/21/2020 | 2020 | Adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C |
| Pizensy | Lactitol | 2/12/2020 | 2020 | Chronic idiopathic constipation (CIC) in adults |
| Tazverik | Tazemetostat | 1/23/2020 | 2020 | Epithelioid sarcoma |
| Tepezza | Teprotumumab-trbw | 1/21/2020 | 2020 | Thyroid eye disease |
| Ayvakit | Avapritinib | 1/9/2020 | 2020 | Adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) |
| Ubrelvy | Ubrogepant | 12/23/2019 | 2019 | Acute treatment of migraine with or without aura in adults |
| Enhertu | Fam-trastuzumab deruxtecan-nxki | 12/20/2019 | 2019 | Metastatic breast cancer |
| Dayvigo | Lemborexant | 12/20/2019 | 2019 | Insomnia |
| Caplyta | Lumateperone tosylate | 12/20/2019 | 2019 | Schizophrenia |
| TissueBlue | Brilliant Blue G Ophthalmic Solution | 12/20/2019 | 2019 | Dye used in eye surgery |
| Padcev | Enfortumab vedotin-ejfv | 12/18/2019 | 2019 | Refractory bladder cancer |
| Vyondys 53 | Golodirsen | 12/12/2019 | 2019 | Certain patients with Duchenne muscular dystrophy |
| Oxbryta | Voxelotor | 11/25/2019 | 2019 | Sickle cell disease |
| Xcopri | Cenobamate | 11/21/2019 | 2019 | Partial onset seizures |
| Givlaari | Givosiran | 11/20/2019 | 2019 | Acute hepatic porphyria, a rare blood disorder |
| Adakveo | Crizanlizumab-tmca | 11/15/2019 | 2019 | Patients with painful complication of sickle cell disease |
| Fetroja | Cefiderocol | 11/14/2019 | 2019 | To treat patients with complicated urinary tract infections who have limited or no alternative treatment options |
| Brukinsa | Zanubrutinib | 11/14/2019 | 2019 | Certain patients with mantle cell lymphoma, a form of blood cancer |
| Reblozyl | Luspatercept–aamt | 11/8/2019 | 2019 | For the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions |
| ExEm Foam | Air polymer-type A | 11/7/2019 | 2019 | A diagnostic agent used to assess fallopian tube patency (openness) in women with known or suspected infertility |
| Trikafta | Elexacaftor/ivacaftor/tezacaftor | 10/21/2019 | 2019 | Patients 12 years of age and older with the most common gene mutation that causes cystic fibrosis |
| Reyvow | Lasmiditan | 10/11/2019 | 2019 | For the acute treatment of migraine with or without aura, in adults |
| Scenesse | Afamelanotide | 10/8/2019 | 2019 | To increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria |
| Beovu | Brolucizumab–dbll | 10/7/2019 | 2019 | Treatment of wet age-related macular degeneration |
| Aklief | Trifarotene | 10/4/2019 | 2019 | For the topical treatment of acne vulgaris in patients 9 years of age and older |
| Ibsrela | Tenapanor | 9/12/2019 | 2019 | Irritable bowel syndrome with constipation in adults. |
| Nourianz | Istradefylline | 8/27/2019 | 2019 | To treat adult patients with Parkinson’s disease experiencing “off” episodes |
| Ga-68-DOTATOC | Ga-68-DOTATOC | 8/21/2019 | 2019 | For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) |
| Xenleta | Lefamulin | 8/19/2019 | 2019 | Adults with community-acquired bacterial pneumonia |
| Rinvoq | Upadacitinib | 8/16/2019 | 2019 | Adults with moderately to severely active rheumatoid arthritis |
| Inrebic | Fedratinib | 8/16/2019 | 2019 | Adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis |
| Rozlytrek | Entrectinib | 8/15/2019 | 2019 | Adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive |
| Wakix | Pitolisant | 8/14/2019 | 2019 | Excessive daytime sleepiness (EDS) in adult patients with narcolepsy |
| Turalio | Pexidartinib | 8/2/2019 | 2019 | Adult patients with symptomatic tenosynovial giant cell tumor |
| Nubeqa | Darolutamide | 7/30/2019 | 2019 | Adult patients with non-metastatic castration resistant prostate cancer |
| Accrufer | Ferric maltol | 7/25/2019 | 2019 | To treat iron deficiency anemia in adults |
| Recarbrio | Imipenem, cilastatin and relebactam | 7/16/2019 | 2019 | Complicated urinary tract and complicated intra-abdominal infections |
| Xpovio | Selinexor | 7/3/2019 | 2019 | Adult patients with relapsed or refractory multiple myeloma (RRMM) |
| Vyleesi | Bremelanotide | 6/21/2018 | 2019 | Hypoactive sexual desire disorder in premenopausal women. |
| Polivy | Polatuzumab vedotin-piiq | 6/10/2019 | 2019 | Adult patients with relapsed or refractory diffuse large B-cell lymphoma |
| Piqray | Alpelisib | 5/24/2019 | 2019 | Breast cancer |
| Vyndaqel | Tafamidis meglumine | 5/3/2019 | 2019 | Heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults |
| Skyrizi | Risankizumab-rzaa | 4/23/2019 | 2019 | Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy |
| Balversa | Erdafitinib | 4/12/2019 | 2019 | Adult patients with locally advanced or metastatic bladder cancer |
| Evenity | Romosozumab-aqqg | 4/9/2019 | 2019 | Osteoporosis in postmenopausal women at high risk of fracture |
| Mayzent | Siponimod | 3/26/2019 | 2019 | Adults with relapsing forms of multiple sclerosis |
| Sunosi | Solriamfetol | 3/20/2019 | 2019 | To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea |
| Zulresso | Brexanolone | 3/19/2019 | 2019 | Postpartum depression (PPD) in adult women |
| Egaten | Triclabendazole | 2/13/2019 | 2019 | Fascioliasis, a parasitic infestation caused by two species of flatworms or trematodes that mainly the affect the liver, sometimes referred to as “liver flukes” |
| Cablivi | Caplacizumab-yhdp | 2/6/2019 | 2019 | Adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) |
| Jeuveau | PrabotulinumtoxinA-xvfs | 2/1/2019 | 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 |
| Ultomiris | Ravulizumab | 12/21/2018 | 2018 | Paroxysmal nocturnal hemoglobinuria (PNH) |
| Elzonris | Tagraxofusp-erzs | 12/21/2018 | 2018 | Blastic plasmacytoid dendritic cell neoplasm (BPDCN) |
| Asparlas | Calaspargase pegol-mknl | 12/20/2018 | 2018 | Acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years |
| Motegrity | Prucalopride | 12/14/2018 | 2018 | Chronic idiopathic constipation |
| Xospata | Gilteritinib | 11/28/2018 | 2018 | Patients who have relapsed or refractory acute myeloid leukemia (AML) |
| Firdapse | Amifampridine | 11/28/2028 | 2018 | To treat Lambert-Eaton myasthenic syndrome (LEMS) in adults |
| Vitrakvi | Larotrectinib | 11/26/2018 | 2018 | Patients whose cancers have a specific genetic feature (biomarker) |
| Daurismo | Glasdegib | 11/21/2018 | 2018 | Newly-diagnosed acute myeloid leukemia (AML) in adult patients |
| Gamifant | Emapalumab-lzsgemapalumab-lzsg | 11/20/2018 | 2018 | Primary hemophagocytic lymphohistiocytosis (HLH) |
| Aemcolo | Rifamycin | 11/16/2018 | 2018 | Travelers’ diarrhea |
| Yupelri | Revefenacin | 11/9/2018 | 2018 | Patients with chronic obstructive pulmonary disease (COPD) |
| Lorbrena | Lorlatinib | 11/2/2018 | 2018 | Patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer |
| Xofluza | Baloxavir marboxil | 10/24/2018 | 2018 | To treat acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours. |
| Talzenna | Talazoparib | 10/16/2018 | 2018 | To treat locally advanced or metastatic breast cancer patients with a germline BRCA mutation. |
| Tegsedi | Inotersen | 10/5/2018 | 2018 | Polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| Revcovi | Elapegademase-lvlr | 10/5/2018 | 2018 | Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID) |
| Nuzyra | Omadacycline | 10/2/2018 | 2018 | Community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections |
| Seysara | Sarecycline | 10/1/2018 | 2018 | Inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older |
| Libtayo | Cemiplimab-rwlc | 9/28/2018 | 2018 | Cutaneous squamous cell carcinoma (CSCC) |
| VizimproExternal Link Disclaimer | Dacomitinib | 9/27/2018 | 2018 | To treat metastatic non-small-cell lung cancer |
| Emgality | Galcanezumab-gnlm | 9/27/2018 | 2018 | For the preventive treatment of migraine in adults |
| Copiktra | Duvelisib | 9/24/2018 | 2018 | Relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma |
| Ajovy | Fremanezumab-vfrm | 9/14/2018 | 2018 | For the preventive treatment of migraine in adults |
| Lumoxiti | Moxetumomab pasudotox-tdfk | 9/13/2018 | 2018 | Hairy cell leukemia |
| Pifeltro | Doravirine | 8/30/2018 | 2018 | HIV-1 infection in adult patients |
| Xerava | Eravacycline | 8/27/2018 | 2018 | To treat complicated intra-abdominal infections in patients 18 years of age and older |
| Takhzyro | Lanadelumab | 8/23/2018 | 2018 | Types I and II hereditary angioedema |
| Oxervate | Cenegermin-bkbj | 8/22/2018 | 2018 | Neurotrophic keratitis |
| Diacomit | Stiripentol | 8/20/2018 | 2018 | Seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam |
| Galafold | Migalastat | 8/10/2018 | 2018 | Treat adults with Fabry disease. |
| Annovera | Segesterone acetate and ethinyl estradiol vaginal system | 8/10/2018 | 2018 | New vaginal ring used to prevent pregnancy for an entire year |
| Onpattro | Patisiran | 8/10/2018 | 2018 | To treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients |
| Poteligeo | Mogamulizumab-kpkc | 8/8/2018 | 2018 | Two rare types of non-Hodgkin lymphoma |
| Mulpleta | Lusutrombopag | 7/31/2018 | 2018 | Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure |
| Omegaven | Fish oil triglycerides | 7/27/2018 | 2018 | As a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis |
| Orilissa | Elagolix sodium | 7/23/2018 | 2018 | For the management of moderate to severe pain associated with endometriosis |
| Krintafel | Tafenoquine | 7/20/2018 | 2018 | For the radical cure (prevention of relapse) of Plasmodium vivax malaria |
| Tibsovo | Ivosidenib | 7/20/2018 | 2018 | Patients with relapsed or refractory acute myeloid leukemia |
| TPOXX | Tecovirimat | 7/13/2018 | 2018 | Smallpox |
| Braftovi | Encorafenib | 6/27/2018 | 2018 | Unresectable or metastatic melanoma |
| Mektovi | Binimetinib | 6/27/2018 | 2018 | Unresectable or metastatic melanoma |
| Zemdri | Plazomicin | 6/25/2018 | 2018 | Adults with complicated urinary tract infections |
| Epidioloex | Cannabidiol | 6/25/2018 | 2018 | Rare, severe forms of epilepsy |
| Moxidectin | Moxidectin | 6/13/2018 | 2018 | Onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older |
| Olumiant | Baricitinib | 5/31/2018 | 2018 | Moderately to severely active rheumatoid arthritis |
| Palynziq | Pegvaliase-pqpz | 5/24/2018 | 2018 | To treat adults with a rare and serious genetic disease known as phenylketonuria (PKU) |
| Doptelet | Avatrombopag | 5/21/2018 | 2018 | Low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure |
| Lokelma | Sodium zirconium cyclosilicate | 5/18/2018 | 2018 | To treat hyperkalemia |
| Aimovig | Erenumab-aooe | 5/17/2018 | 2018 | For the preventive treatment for migraine |
| Lucemyra | Lofexidine hydrochloride | 5/16/2018 | 2018 | For the non-opioid treatment for management of opioid withdrawal symptoms in adults |
| Akynzeo | Fosnetupitant and palonosetron | 4/19/2018 | 2018 | To prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy |
| Crysvita | Burosumab-twza | 4/17/2018 | 2018 | Adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets |
| Tavalisse | Fostamatinib | 4/17/2018 | 2018 | Thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP) |
| Ilumya | Tildrakizumab | 3/20/2018 | 2018 | Adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy |
| Trogarzo | Ibalizumab-uiyk | 3/6/2018 | 2018 | HIV patients who have limited treatment options |
| Erleada | Apalutamide | 2/14/2018 | 2018 | A certain type of prostate cancer using novel clinical trial endpoint |
| Symdeko | Tezacaftor; ivacaftor | 2/12/2018 | 2018 | Cystic fibrosis in patients age 12 years and older |
| Biktarvy | Bictegravir, embitcitabine, tenofovir alafenamide | 2/7/2018 | 2018 | Infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen |
| Lutathera | Lutetium Lu 177 dotatate | 1/26/2018 | 2018 | A type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). |
| Giapreza | Angiotensin II | 12/21/2017 | 2017 | To increase blood pressure in adults with septic or other distributive shock |
| Macrilen | Macimorelin acetate | 12/20/2017 | 2017 | For the diagnosis of adult growth hormone deficiency |
| Steglatro | Ertugliflozin | 12/19/2017 | 2017 | To improve glycemic control in adults with type 2 diabetes mellitus |
| Rhopressa | Netarsudil | 12/18/2017 | 2017 | Glaucoma or ocular hypertension |
| Xepi | Ozenoxacin | 12/11/2017 | 2017 | Impetigo |
| Ozempic | Semaglutide | 12/5/2017 | 2017 | To improve glycemic control in adults with type 2 diabetes mellitus |
| Hemlibra | Emicizumab | 11/16/2017 | 2017 | To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. |
| Mepsevii | Vestronidase alfa-vjbk | 11/15/2017 | 2017 | Pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. |
| Fasenra | Benralizumab | 11/14/2017 | 2017 | For add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype |
| Prevymis | Letermovir | 11/8/2017 | 2017 | To prevent infection after bone marrow transplant |
| Vyzulta | Latanoprostene bunod ophthalmic solution | 11/2/2017 | 2017 | Intraocular pressure in patients with open-angle glaucoma or ocular hypertension. |
| Calquence | Acalabrutinib | 10/31/2017 | 2017 | Adults with mantle cell lymphoma |
| Verzenio | Abemaciclib | 9/28/2017 | 2017 | Certain advanced or metastatic breast cancers |
| Solosec | Secnidazole | 9/15/2017 | 2017 | Bacterial vaginosis |
| Aliqopa | Copanlisib | 9/14/2017 | 2017 | Adults with relapsed follicular lymphoma |
| benznidazole | Benznidazole | 8/29/2017 | 2017 | Children ages 2 to 12 years old with Chagas disease |
| Vabomere | Meropenem and vaborbactam | 8/29/2017 | 2017 | Adults with complicated urinary tract infections |
| Besponsa | Inotuzumab ozogamicin | 8/17/2017 | 2017 | Adults with relapsed or refractory acute lymphoblastic leukemia |
| Mavyret | Glecaprevir and pibrentasvir | 8/3/2017 | 2017 | Adults with chronic hepatitis C virus |
| Idhifa | Enasidenib | 8/1/2017 | 2017 | Relapsed or refractory acute myeloid leukemia |
| Vosevi | Sofosbuvir, velpatasvir and voxilaprevir | 7/18/2017 | 2017 | Adults with chronic hepatitis C virus |
| Nerlynx | Neratinib maleate | 7/17/2017 | 2017 | To reduce the risk of breast cancer returning |
| Tremfya | Guselkumab | 7/13/2017 | 2017 | For the treatment of adult patients with moderate-to-severe plaque psoriasis |
| Bevyxxa | Betrixaban | 6/23/2017 | 2017 | For the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness |
| Baxdela | Delafloxacin | 6/19/2017 | 2017 | Patients with acute bacterial skin infections |
| Kevzara | Sarilumab | 5/22/2017 | 2017 | Adult rheumatoid arthritis |
| Radicava | Edaravone | 5/5/2017 | 2017 | Patients with amyotrophic lateral sclerosis (ALS) |
| Imfinzi | Durvalumab | 5/1/2017 | 2017 | Patients with locally advanced or metastatic urothelial carcinoma |
| Tymlos | Abaloparatide | 4/28/2017 | 2017 | Osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies |
| Rydapt | Midostaurin | 4/28/2017 | 2017 | Acute myeloid leukemia, advanced systemic mastocytosis |
| Alunbrig | Brigatinib | 4/28/2017 | 2017 | Patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib |
| Brineura | Cerliponase alfa | 4/27/2017 | 2017 | A specific form of Batten disease |
| Ingrezza | Valbenazine | 4/11/2017 | 2017 | Adults with tardive dyskinesia |
| Austedo | Deutetrabenazine | 4/3/2017 | 2017 | For the treatment of chorea associated with Huntington’s disease |
| Ocrevus | Ocrelizumab | 3/28/2017 | 2017 | Patients with relapsing and primary progressive forms of multiple sclerosis |
| Dupixent | Dupilumab | 3/28/2017 | 2017 | Adults with moderate-to-severe eczema (atopic dermatitis) |
| Zejula | Niraparib | 3/27/2017 | 2017 | For the maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers |
| Symproic | Naldemedine | 3/23/2017 | 2017 | For the treatment of opioid-induced constipation |
| Bavencio | Avelumab | 3/23/2017 | 2017 | Metastatic Merkel cell carcinoma |
| Xadago | Safinamide | 3/21/2017 | 2017 | Parkinson’s disease |
| Kisqali | Ribociclib | 3/13/2017 | 2017 | Postmenopausal women with a type of advanced breast cancer |
| Xermelo | Telotristat ethyl | 2/28/2017 | 2017 | Carcinoid syndrome diarrhea |
| Siliq | Brodalumab | 2/15/2017 | 2017 | Adults with moderate-to-severe plaque psoriasis |
| Emflaza | Deflazacort | 2/9/2017 | 2017 | Patients age 5 years and older with Duchenne muscular dystrophy (DMD) |
| Parsabiv | Etelcalcetide | 2/7/2017 | 2017 | Secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis |
| Trulance | Plecanatide | 1/19/2017 | 2017 | Chronic Idiopathic Constipation (CIC) in adult patients. |
| Spinraza | Nusinersen | 12/23/2016 | 2016 | Children and adults with spinal muscular atrophy (SMA) |
| Rubraca | Rucaparib | 12/19/2016 | 2016 | Women with a certain type of ovarian cancer |
| Eucrisa | Crisaborole | 12/14/2016 | 2016 | Mild to moderate eczema (atopic dermatitis) in patients two years of age and older |
| Zinplava | Bezlotoxumab | 10/21/2016 | 2016 | To reduce the recurrence of Clostridium difficile infection in patients aged 18 years or older |
| Lartruvo | Olaratumab | 10/19/2016 | 2016 | Adults with certain types of soft tissue sarcoma |
| Exondys 51 | Eteplirsen | 9/19/2016 | 2016 | Patients with Duchenne muscular dystrophy |
| Adlyxin | Lixisenatide | 7/27/2016 | 2016 | To improve glycemic control (blood sugar levels) |
| Xiidra | Lifitegrast ophthalmic solution | 7/11/2016 | 2016 | To treat the signs and symptoms of dry eye disease |
| Epclusa | Sofosbuvir and velpatasvir | 6/28/2016 | 2016 | All six major forms of hepatitis C virus |
| NETSPOT | Gallium Ga 68 dotatate | 6/1/2016 | 2016 | A diagnostic imaging agent to detect rare neuroendocrine tumors |
| Axumin | Fluciclovine F 18 | 5/27/2016 | 2016 | A new diagnostic imaging agent to detect recurrent prostate cancer |
| Ocaliva | Obeticholic acid | 5/27/2016 | 2016 | Rare, chronic liver disease |
| Zinbryta | Daclizumab | 5/27/2016 | 2016 | Multiple sclerosis |
| Tecentriq | Atezolizumab | 5/18/2016 | 2016 | To treat urothelial carcinoma, the most common type of bladder cancer |
| Nuplazid | Pimavanserin | 4/29/2016 | 2016 | Hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease |
| Venclexta | Venetoclax | 4/11/2016 | 2016 | For chronic lymphocytic leukemia in patients with a specific chromosomal abnormality |
| Defitelio | Defibrotide sodium | 3/30/2016 | 2016 | To treat adults and children who develop hepatic veno-occlusive disease with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation |
| Cinqair | Reslizumab | 3/23/2016 | 2016 | Severe asthma |
| Taltz | Ixekizumab | 3/22/2016 | 2016 | Adults with moderate-to-severe plaque psoriasis. |
| Anthim | Obiltoxaximab | 3/18/2016 | 2016 | Inhalational anthrax in combination with appropriate antibacterial drugs. |
| Briviact | Brivaracetam | 2/18/2016 | 2016 | Partial onset seizures in patients age 16 years and older with epilepsy. |
| Zepatier | Elbasvir and grazoprevir | 1/28/2016 | 2016 | Patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. |
| Zurampic | Lesinurad | 12/22/2015 | 2015 | High blood uric acid levels associated with gout |
| Uptravi | Selexipag | 12/21/2015 | 2015 | Pulmonary arterial hypertension |
| Bridion | Sugammadex | 12/15/2015 | 2015 | To reverse effects of neuromuscular blocking drugs used during surgery |
| Alecensa | Alectinib | 12/11/2015 | 2015 | ALK-positive lung cancer |
| Kanuma | Sebelipase alfa | 12/8/2015 | 2015 | Patients with a rare disease known as lysosomal acid lipase (LAL) deficiency |
| Empliciti | Elotuzumab | 11/30/2015 | 2015 | People with multiple myeloma who have received one to three prior medications |
| Portrazza | Necitumumab | 11/24/2015 | 2015 | Patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer |
| Ninlaro | Ixazomib | 11/20/2015 | 2015 | People with multiple myeloma who have received at least one prior therapy |
| Darzalex | Daratumumab | 11/16/2015 | 2015 | Patients with multiple myeloma who have received at least three prior treatments. |
| Tagrisso | Osimertinib | 11/13/2015 | 2015 | Certain patients with non-small cell lung cancer |
| Cotellic | Cobimetinib | 11/10/2015 | 2015 | To be used in combination with vemurafenib advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation) |
| Genvoya | A fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide | 11/5/2015 | 2015 | For use as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older |
| Nucala | Mepolizumab | 11/4/2015 | 2015 | For use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. |
| Strensiq | Asfotase alfa | 10/23/2015 | 2015 | Perinatal, infantile and juvenile-onset hypophosphatasia (HPP). |
| Yondelis | Trabectedin | 10/23/2015 | 2015 | To treat specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). |
| Veltassa | Patiromer for oral suspension | 10/21/2015 | 2015 | Hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. |
| Praxbind | Idarucizumab | 10/16/2015 | 2015 | For use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects. |
| Aristada | Aripiprazole lauroxil | 10/5/2015 | 2015 | Adults with schizophrenia |
| Tresiba | Insulin degludec injection | 9/25/2015 | 2015 | To improve blood sugar (glucose) control in adults with diabetes mellitus |
| Lonsurf | Trifluridine and tipiracil | 9/22/2015 | 2015 | Patients with an advanced form of colorectal cancer who are no longer responding to other therapies |
| Vraylar | Cariprazine | 9/17/2015 | 2015 | Schizophrenia and bipolar disorder in adults |
| Xuriden | Uridine triacetate | 9/4/2015 | 2015 | Patients with hereditary orotic aciduria |
| Varubi | Rolapitant | 9/1/2015 | 2015 | To prevent delayed phase chemotherapy-induced nausea and vomiting (emesis) |
| Repatha | Evolocumab | 8/27/2015 | 2015 | Certain patients with high cholesterol |
| Addyi | Flibanserin | 8/18/2015 | 2015 | Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women |
| Daklinza | Daclatasvir | 7/24/2015 | 2015 | Chronic hepatitis C virus (HCV) genotype 3 infections |
| Odomzo | Sonidegib | 7/24/2015 | 2015 | Patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy. |
| Praluent | Alirocumab | 7/24/2015 | 2015 | Certain patients with high cholesterol |
| Rexulti | Brexpiprazole | 7/10/2015 | 2015 | Schizophrenia and as an add on to an antidepressant major depressive disorder |
| Entresto | Sacubitril/valsartan | 7/7/2015 | 2015 | Heart failure |
| Orkambi | Lumacaftor 200 mg/ivacaftor 125 mg | 7/2/2015 | 2015 | Cystic fibrosis |
| Kengreal | Cangrelor | 6/22/2015 | 2015 | To prevent the formation of harmful blood clots in the coronary arteries for adult patients undergoing percutaneous coronary intervention |
| Viberzi | Eluxadoline | 5/27/2015 | 2015 | To treat irritable bowel syndrome with diarrhea (IBS-D) in adult men and women. |
| Kybella | Deoxycholic acid | 4/29/2015 | 2015 | Adults with moderate-to-severe fat below the chin, known as submental fat |
| Corlanor | Ivabradine | 4/15/2015 | 2015 | To reduce hospitalization from worsening heart failure. |
| Cholbam | Cholic acid | 3/17/2015 | 2015 | Pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders |
| Unituxin | Dinutuximab | 3/10/2015 | 2015 | Pediatric patients with high-risk neuroblastoma |
| Cresemba | Isavuconazonium sulfate | 3/6/2015 | 2015 | Adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections |
| Avycaz | Ceftazidime-avibactam | 2/25/2015 | 2015 | Adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options. |
| Farydak | Panobinostat | 2/23/2015 | 2015 | Patients with multiple myeloma |
| Lenvima | Lenvatinib | 2/13/2015 | 2015 | Patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). |
| Ibrance | Palbociclib | 2/3/2015 | 2015 | Advanced (metastatic) breast cancer |
| Natpara | Parathyroid horomone | 1/23/2015 | 2015 | To control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism |
| Cosentyx | Secukinumab | 1/21/2015 | 2015 | Adults with moderate-to-severe plaque psoriasis |
| Savaysa | Edoxaban | 1/8/2015 | 2015 | To reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem |
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