The US FDA approved 42 novel drugs in 2019. This was down from 59 approved in 2018. Swiss pharma giant (NVS) was the only company with four drugs approved. The complete list of drugs approved by the FDA in 2019 are shown in the table below:
| 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 Press Release Drug Trials Snapshot |
| 47. | Enhertu | fam-trastuzumab deruxtecan-nxki | 12/20/2019 | To treat metastatic breast cancer Press Release Drug Trials Snapshot |
| 46 | Dayvigo | lemborexant | 12/20/2019 | To treat insomnia Drug Trials Snapshot |
| 45. | Caplyta | lumateperone tosylate | 12/20/2019 | To treat schizophrenia Drug Trials Snapshot |
| 44. | TissueBlue | Brilliant Blue G Ophthalmic Solution | 12/20/2019 | Dye used in eye surgery Drug Trials Snapshot |
| 43. | Padcev | enfortumab vedotin-ejfv | 12/18/2019 | To treat refractory bladder cancer Press Release Drug Trials Snapshot |
| 42. | Vyondys 53 | golodirsen | 12/12/2019 | To treat certain patients with Duchenne muscular dystrophy Press Release Drug Trials Snapshot |
| 41. | Oxbryta | voxelotor | 11/25/2019 | To treat sickle cell disease Press Release Drug Trials Snapshot |
| 40. | Xcopri | cenobamate | 11/21/2019 | To treat partial onset seizures Press Release Drug Trials Snapshot |
| 39. | Givlaari | givosiran | 11/20/2019 | To treat acute hepatic porphyria, a rare blood disorder Press Release Drug Trials Snapshot |
| 38. | Adakveo | crizanlizumab-tmca | 11/15/2019 | To treat patients with painful complication of sickle cell disease Press Release Drug Trials Snapshot |
| 37. | Fetroja | cefiderocol | 11/14/2019 | To treat patients with complicated urinary tract infections who have limited or no alternative treatment options Press Release Drug Trials Snapshot |
| 36. | Brukinsa | zanubrutinib | 11/14/2019 | To treat certain patients with mantle cell lymphoma, a form of blood cancer Press Release Drug Trials Snapshot |
| 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 Press Release Drug Trials Snapshot |
| 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 Drug Trials Snapshot |
| 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 Press Release Drug Trials Snapshot |
| 32. | Reyvow | lasmiditan | 10/11/2019 | For the acute treatment of migraine with or without aura, in adults Press Release Drug Trials Snapshots |
| 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) Drug Trials Snapshot |
|
| 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 Press Release Drug Trials Snapshot |
| 29. | Beovu | brolucizumab–dbll | 10/7/2019 | Treatment of wet age-related macular degeneration Drug Trials Snapshot |
| 28. | Aklief | trifarotene | 10/4/2019 | For the topical treatment of acne vulgaris in patients 9 years of age and older Drug Trials Snapshot |
| 27. | Ibsrela | tenapanor | 9/12/2019 | To treat irritable bowel syndrome with constipation in adults. Drug Trials Snapshot |
| 26. | Nourianz | istradefylline | 8/27/2019 | To treat adult patients with Parkinson’s disease experiencing “off” episodes Press Release Drug Trials Snapshot |
| 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) Drug Trials Snapshot |
| 24. | Xenleta | lefamulin | 8/19/2019 | To treat adults with community-acquired bacterial pneumonia Press Release Drug Trials Snapshot |
| 23. | Rinvoq | upadacitinib | 8/16/2019 | To treat adults with moderately to severely active rheumatoid arthritis Drug Trials Snapshot |
| 22. | Inrebic | fedratinib | 8/16/2019 | To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis Press Release Drug Trials Snapshot |
| 21. | Rozlytrek | entrectinib | 8/15/2019 | To treat adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive To treat adult and pediatric patients 12 years of age and older with solid tumors Press Release Drug Trials Snapshot: Pediatric patients 12 years of age and older with solid tumors Drug Trials Snapshot: 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 Drug Trials Snapshot |
| 19. | pretomanid | 8/14/2019 | For treatment-resistant forms of tuberculosis that affects the lungs Press Release Drug Trials Snapshot |
|
| 18. | Turalio | pexidartinib | 8/2/2019 | To treat adult patients with symptomatic tenosynovial giant cell tumor Press Release Drug Trials Snapshot |
| 17. | Nubeqa | darolutamide | 7/30/2019 | To treat adult patients with non-metastatic castration resistant prostate cancer Drug Trials Snapshot |
| 16. | Accrufer | ferric maltol | 7/25/2019 | To treat iron deficiency anemia in adults Drug Trials Snapshot |
| 15. | Recarbrio | imipenem, cilastatin and relebactam | 7/16/2019 | To treat complicated urinary tract and complicated intra-abdominal infections Press Release Drug Trials Snapshot |
| 14. | Xpovio | selinexor | 7/3/2019 | To treat adult patients with relapsed or refractory multiple myeloma (RRMM) Press Release Drug Trials Snapshot |
| 13. | Vyleesi | bremelanotide | 6/21/2018 | To treat hypoactive sexual desire disorder in premenopausal women. Press Release Drug Trials Snapshot |
| 12. | Polivy | polatuzumab vedotin-piiq | 6/10/2019 | To treat adult patients with relapsed or refractory diffuse large B-cell lymphoma Press Release Drug Trials Snapshot |
| 11. | Piqray | alpelisib | 5/24/2019 | To treat breast cancer Press Release Drug Trials Snapshot |
| 10. | Vyndaqel | tafamidis meglumine | 5/3/2019 | To treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults Press Release Drug Trials Snapshot |
| 9. | Skyrizi | risankizumab-rzaa | 4/23/2019 | To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Drug Trials Snapshot |
| 8. | Balversa | erdafitinib | 4/12/2019 | To treat adult patients with locally advanced or metastatic bladder cancer Press Release Drug Trials Snapshot |
| 7. | Evenity | romosozumab-aqqg | 4/9/2019 | To treat osteoporosis in postmenopausal women at high risk of fracture Press Release Drug Trials Snapshot |
| 6. | Mayzent | siponimod | 3/26/2019 | To treat adults with relapsing forms of multiple sclerosis Press Release Drug Trials Snapshot |
| 5. | Sunosi | solriamfetol | 3/20/2019 | To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea Drug Trials Snapshot |
| 4. | Zulresso | brexanolone | 3/19/2019 | To treat postpartum depression (PPD) in adult women Press Release Drug Trials Snapshot |
| 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” Drug Trials Snapshot |
| 2. | Cablivi | caplacizumab-yhdp | 2/6/2019 | To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) Press Release Drug Trials Snapshot |
| 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 |
Source: FDA
For more details you can visit the FDA site.
Disclosure: No Positions
