2019 FDA novel drugs approvals

48. Ubrelvyubrogepant 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. Caplytalumateperone tosylate 12/20/2019 To treat schizophrenia

44. TissueBlue BrilliantBlue 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 53golodirsen 12/12/2019 To treat certain patients with Duchenne muscular dystrophy

41. Oxbrytavoxelotor 11/25/2019 To treat sickle cell disease

40. Xcopricenobamate 11/21/2019 To treat partial onset seizures

39. Givlaarigivosiran 11/20/2019 To treat acute hepatic porphyria, a rare blood disorder

38. Adakveocrizanlizumab-tmca 11/15/2019 To treat patients with painful complication of sickle cell disease

37. Fetrojacefiderocol 11/14/2019 To treat patients with complicated urinary tract infections who have limited or no alternative treatment options

36. Brukinsazanubrutinib 11/14/2019 To treat certain patients with mantle cell lymphoma, a form of blood cancer

35. Reblozylluspatercept–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. Reyvowlasmiditan 10/11/2019 For the acute treatment of migraine with or without aura, in adults

31. fluorodopa F 1810/10/2019 A diagnostic agent for use in positron emission tomography (PET) to help diagnose adult patients with suspected Parkinsonian syndromes (PS)

30. Scenesseafamelanotide 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. Beovubrolucizumab–dbll 10/7/2019 Treatment of wet age-related macular degeneration

28. Aklieftrifarotene 10/4/2019 For the topical treatment of acne vulgaris in patients 9 years of age and older

27. Ibsrelatenapanor 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-DOTATOCGa-68-DOTATOC 8/21/2019 For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs)

23. Rinvoqupadacitinib 8/16/2019 To treat adults with moderately to severely active rheumatoid arthritis

22. Inrebicfedratinib 8/16/2019 To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis

21. Rozlytrekentrectinib 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. Wakixpitolisant 8/14/2019 To treat excessive daytime sleepiness (EDS) in adult patients with narcolepsy

19. pretomanid8/14/2019 For treatment-resistant forms of tuberculosis that affects the lungs

18. Turaliopexidartinib 8/2/2019 To treat adult patients with symptomatic tenosynovial giant cell tumor

17. Nubeqadarolutamide 7/30/2019 To treat adult patients with non-metastatic castration resistant prostate cancer

16. Accruferferric 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. Xpovioselinexor 7/3/2019 To treat adult patients with relapsed or refractory multiple myeloma (RRMM)

13. Vyleesibremelanotide 6/21/2018 To treat hypoactive sexual desire disorder in premenopausal women.

12. Polivypolatuzumab vedotin-piiq 6/10/2019 To treat adult patients with relapsed or refractory diffuse large B-cell lymphoma

11. Piqrayalpelisib 5/24/2019 To treat breast cancer

10. Vyndaqeltafamidis 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. Balversaerdafitinib 4/12/2019 To treat adult patients with locally advanced or metastatic bladder cancer

7. Evenityromosozumab-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. Sunosisolriamfetol 3/20/2019 To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea

4. Zulressobrexanolone 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. Cablivicaplacizumab-yhdp 2/6/2019 To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP)

1. JeuveauprabotulinumtoxinA-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 https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019

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