A comprehensive table of the 48 new drug approvals and their corresponding active ingredients, diseases, estimated sales, and companies.
Let's start the new year off with a little past reflection! In the year 2019, the FDA’s Center for Drug Evaluation and Research (CDER) approved 48 new molecular entities, down from 59 in 2018 and 46 in 2017.
We have organized the 48 new drugs chronologically in a list below based on their corresponding approval dates.
This list only includes CDER drug approvals of 2019, and excludes vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2019 by the Center for Biologics Evaluation and Research.
Be on the lookout for an upcoming blog that includes the previously mentioned exclusions!
| Drug Name | Approval Date | Active ingredient | Disease | Peak Sales Estimate | Company |
| 1. Jeuveau | Feb. 1, 2019 | prabotulinumtoxinA-xfvs | Frown lines | $250 million in 2025 |
|
| 2. Cablivi | Feb. 6, 2019 | caplacizumab-yhdp | Acquired thrombotic thrombocytopenic purpura | $500 million | |
| 3. Egaten | Feb. 13, 2019 | triclabendazole | Fascioliasis (liver fluke infection) | N/A | |
| 4. Zulresso | March 19, 2019 | brexanolone | Postpartum depression | $370 million | |
| 5. Sunosi | March 21, 2019 | solriamfetol | Sleepiness due to obstructive sleep apnea | $500 million | |
| 6. Mayzent | March 26, 2019 | siponimod | Secondary progressive multiple sclerosis | $1.3 billion | |
| 7. Evenity | April 9, 2019 | romosozumab | Osteoporosis | over $500 million | |
| 8. Balversa | April 12, 2019 | erdafitinib | Bladder cancer | over $1 billion | |
| 9. Skyrizi | April 23, 2019 | risankizumab-rzaa | Psoriasis, other inflammatory disorders | $3 billion to $5 billion | |
| 10. Vyndaqel | May 3, 2019 | tafamidis meglumine | Transthyretin-mediated amyloidosis cardiomyopathy | $1.5 billion | |
| 11. Piqray | May 27, 2019 | alpelisib | Breast cancer | N/A | |
| 12. Polivy | June 10, 2019 | polatuzumab vedotin | Diffuse large B-cell lymphoma | $1 billion | |
| 13. Vyleesi | June 21, 2019 | bremelanotide | Hypoactive sexual desire disorder | $170 million | |
| 14. Xpovio | July 3, 2019 | selinexor | Relapsed or refractory multiple myeloma (RRMM) in adults | N/A | |
| 15. Recarbrio | July 17, 2019 | imipenem, cilastatin, and relebactam | Complicated UTIs and abdominal infections | N/A | |
| 16. Accrufer | July 25, 2019 | ferric maltol | Iron deficiency anemia in adults | N/A | |
| 17. Nubeqa | July 30, 2019 | darolutamide | Prostate cancer | €480 million to €1 billion | |
| 18. Turalio | Aug. 2, 2019 | pexidartinib | Tenosynovial giant cell tumor | N/A | |
| 19. Pretomanid | Aug. 14, 2019 | pretomanid | Drug-resistant tuberculosis | N/A | |
| 20. Wakix | Aug. 15, 2019 | pitolisant | Narcolepsy | N/A | |
| 21. Rozlytrek | Aug. 15, 2019 | entrectinib | ROS1-positive non-small cell lung cancer and NTRK fusion-positive tumors | $700 million | |
| 22. Inrebic | Aug. 16, 2019 | fedratinib | Myelofibrosis | $400 million |
|
| 23. Rinvoq | Aug. 16, 2019 | upadacitinib | Rheumatoid arthritis | $2.2 billion by 2023 | |
| 24. Xenleta | Aug. 19, 2019 | lefamulin | Community-acquired bacterial pneumonia | N/A | |
| 25. Ga 68 DOTATOC | Aug. 21, 2019 | Ga 68 DOTATOC | Diagnostic agent for neuroendocrine tumors | N/A | |
| 26. Nourianz | Aug. 27, 2019 | istradefylline | Parkinson’s disease | N/A | |
| 27. Ibsrela | Sept. 12, 2019 | tenapanor | Irritable bowel syndrome with constipation | N/A | |
| 28. Aklief | Oct. 4, 2019 | trifarotene | Acne | N/A | |
| 29. Beovu | Oct. 8, 2019 | brolucizumab | Wet age-related macular degeneration | $1 billion | |
| 30. Scenesse | Oct. 9, 2019 | afamelanotide | Erythropoietic protoporphyria | N/A | |
| 31. Fluorodopa F 18 | Oct. 10, 2019 | fluorodopa F 18 | Diagnostic agent for Parkinsonian syndromes | N/A |
|
| 32. Reyvow | Oct. 11, 2019 | lasmiditan | Migraine | ~$500 million | |
| 33. Trikafta | Oct. 21, 2019 | elexacaftor/ivacaftor/tezacaftor | Cystic fibrosis | $6.6 billion by 2025 | |
| 34. ExEm Foam | Nov. 7, 2019 | air polymer-type A | Assess fallopian tube patency (openness) in women with known or suspected infertility | N/A | |
| 35. Reblozyl | Nov. 8, 2019 | luspatercept–aamt | Anemia in patients with beta thalassemia | $2 billion | |
| 36. Brukinsa | Nov. 14, 2019 | zanubrutinib | Mantle cell lymphoma | $2.2 billion (2025) | |
| 37. Fetroja | Nov. 15, 2019 | cefiderocol | Urinary tract infections | N/A | |
| 38. Adakveo | Nov. 15, 2019 | crizanlizumab | Sickle cell disease | over $1 billion | |
| 39. Givlaari | Nov. 20, 2019 | givosiran | Acute hepatic porphyria | $500 million | |
| 40. Xcopri | Nov. 21, 2019 | cenobamate | Partial-onset adult seizures | $840 million | |
| 41. Oxbryta | Nov. 25, 2019 | voxelotor | Sickle cell disease | $2.5 billion | |
| 42. Vyondys 53 | Dec. 12, 2019 | golodirsen | Duchenne muscular dystrophy | $220 million | |
| 43. Padcev | Dec. 18, 2019 | enfortumab vedotin | Metastatic bladder cancer | >$5 billion | |
| 44. TissueBlue | Dec. 20, 2019 | Brilliant Blue G Ophthalmic Solution | Dye used in eye surgery | N/A | |
| 45. Caplyta | Dec. 20, 2019 | lumateperone tosylate | Schizophrenia | $60 million in 2020, $400 million by 2024 | |
| 46. Dayvigo | Dec. 20, 2019 | lemborexant | Insomnia | $1.1 billion | |
| 47. Enhertu | Dec. 20, 2019 | fam-trastuzumab deruxtecan-nxki | HER2-positive breast cancer | $2.5 billion | |
| 48. Ubrelvy | Dec. 23, 2019 | ubrogepant | Migraine | $302 million |
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Sources:
Center for Drug Evaluation and Research. “Novel Drug Approvals for 2019.” U.S. Food and Drug Administration, FDA, 2020, www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019.
Idrus, Amirah Al. “With 45 New Drug Approvals in 2019, 'Friendly' FDA Is Here to Stay.” FierceBiotech, 2 Jan. 2020, www.fiercebiotech.com/special-report/2019-s-new-drug-approvals.