| 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
To treat adult and pediatric patients 12 years of age and older with solid tumors |
| 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 |
| 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 |
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Pharma Sources Insight June 2024: Globalization on the Go
