42 novel drugs were FDA-approved in 2019 compared to 59 drugs the year before.
Below, we have put together these new FDA-approvals – though the table does not include allergenic or blood or vaccine-related products. Similarly, plasma derivatives or gene therapy products are not included.
See below for a full list of FDA approvals and, for more information, visit the FDA website.
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| Drug | Active Ingredient | Date Approved | Indication |
| Ubrelvy | ubrogepant | 12/23/2019 | Acute treatment of migraine with or without aura in adults |
| Enhertu | fam-trastuzumab deruxtecan-nxki | 12/20/2019 | Metastatic breast cancer |
| Dayvigo | lemborexant | 12/20/2019 | Insomnia |
| Caplyta | lumateperonetosylate | 12/20/2019 | Schizophrenia |
| TissueBlue | Brilliant Blue G Ophthalmic Solution | 12/20/2019 | Dye used in eye surgery |
| Padcev | enfortumabvedotin-ejfv | 12/18/2019 | Refractory bladder cancer |
| Vyondys 53 | golodirsen | 12/12/2019 | Duchenne muscular dystrophy |
| Oxbryta | voxelotor | 11/25/2019 | Sickle cell disease |
| Xcopri | cenobamate | 11/21/2019 | Partial onset seizures |
| Givlaari | givosiran | 11/20/2019 | Acute hepatic porphyria |
| Adakveo | crizanlizumab-tmca | 11/15/2019 | Patients with painful complication of sickle cell disease |
| Fetroja | cefiderocol | 11/14/2019 | To treat patients with complicated urinary tract infections who have limited or no alternative treatment options |
| Brukinsa | zanubrutinib | 11/14/2019 | To treat certain patients with mantle cell lymphoma, a form of blood cancer |
| Reblozyl | luspatercept–aamt | 11/8/2019 | Anemia in adult patients with beta thalassemia who require regular erythrocyte transfusions |
| 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 |
| 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 |
| Reyvow | lasmiditan | 10/11/2019 | Migraine with or without aura, in adults |
| 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) | |
| Scenesse | afamelanotide | 10/8/2019 | To increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria |
| Beovu | brolucizumab–dbll | 10/7/2019 | Treatment of wet age-related macular degeneration |
| Aklief | trifarotene | 10/4/2019 | Acne vulgaris in patients 9 years of age and older (topical use) |
| Ibsrela | tenapanor | 9/12/2019 | Irritable bowel syndrome with constipation in adults. |
| Nourianz | istradefylline | 8/27/2019 | Parkinson’s disease in those experiencing “off” episodes |
| 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) |
| Xenleta | lefamulin | 8/19/2019 | Community-acquired bacterial pneumonia |
| Rinvoq | upadacitinib | 8/16/2019 | Rheumatoid arthritis |
| Inrebic | fedratinib | 8/16/2019 | To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis |
| Rozlytrek | entrectinib | 8/15/2019 | Metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive |
| Wakix | pitolisant | 8/14/2019 | Excessive daytime sleepiness (EDS) in adult patients with narcolepsy |
| pretomanid | 8/14/2019 | For treatment-resistant forms of tuberculosis | |
| Turalio | pexidartinib | 8/2/2019 | Symptomatictenosynovial giant cell tumor |
| Nubeqa | darolutamide | 7/30/2019 | Non-metastatic castration resistant prostate cancer |
| Accrufer | ferric maltol | 7/25/2019 | Iron deficiency anemia in adults |
| Recarbrio | imipenem cilastatin relebactam | 7/16/2019 | Complicated urinary tract and complicated intra-abdominal infections |
| Xpovio | selinexor | 7/3/2019 | Adult patients with relapsed or refractory multiple myeloma (RRMM) |
| Vyleesi | bremelanotide | 6/21/2018 | Hypoactive sexual desire disorder in premenopausal women. |
| Polivy | polatuzumabvedotin-piiq | 6/10/2019 | Adult patients with relapsed or refractory diffuse large B-cell lymphoma |
| Piqray | alpelisib | 5/24/2019 | Breast cancer |
| Vyndaqel | tafamidis meglumine | 5/3/2019 | Cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults |
| Skyrizi | risankizumab-rzaa | 4/23/2019 | Plaque psoriasis in adults who are candidates for systemic therapy or phototherapy |
| Balversa | erdafitinib | 4/12/2019 | Advanced or metastatic bladder cancer |
| Evenity | romosozumab-aqqg | 4/9/2019 | Osteoporosis in postmenopausal women at high risk of fracture |
| Mayzent | siponimod | 3/26/2019 | Relapsing forms of multiple sclerosis |
| Sunosi | solriamfetol | 3/20/2019 | To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea |
| Zulresso | brexanolone | 3/19/2019 | Postpartum depression (PPD) in adult women |
| Egaten | triclabendazole | 2/13/2019 | Fascioliasis |
| Cablivi | caplacizumab-yhdp | 2/6/2019 | Acquired thrombotic thrombocytopenic purpura (aTTP) |
| 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 |
