FDA Approved Drugs List 2019

FDA Approved Drugs List 2019
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The US Food and Drug Administration has released a full list of its drug approvals for 2019, showing a total of 48 positive decisions from the Center for Biologics Evaluation and Research (CDER).

Here the list of Drugs 


S.N. Brand Name  Generic Name  Approved Date Uses
1. Jeuveau  PrabotulinumtoxinA-xvfs 2019-2-1 For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator & /or procerus muscle activity in adult patients
2. Cablivi  Caplacizumab-yhdp 2019-2-6 Acquired thrombatic thrombocytopenic purpura
3. Egaten Triclabendazole  2019-2-13 For Fascioliasis 
4. Zulresso Brexanolone 2019-3-19 Postpartum depression in adult women
5. Sunosi  Solriamfetol  2019-3-20 For the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
6. Mayzent  Siponimod  2019-3-26 Relapsing forms of multiple sclerosis 
7. Evenity  Romosozumab-aqqg 2019-4-9 Osteoporosis in postmenopausal women at high risk fracture 
8. Balversa Erdafitinib 2019-4-12 Metastatic bladder cancer
9. Skyrizi  Risankizumab-rzaa 2019-4-23 Plaque psoriasis in adults who are candidates for systemic therapy/Phototherapy 
10. Vyndaqel  Tafamidis meglumine 2019-5-3 Cardiomyopathy in adults 
11. Piqray Alpelisib  2019-5-24 Breast Cancer 
12. Polivy  Polatuzumabvedotin-piiq 2019-6-10 Patient with relapsed/refractory diffuse large B-cell lymphoma in adult 
13. Vyleesi Bremelanotide  2019-6-21 Hypoactive sexual desire disorder in premenopausal women.
14. Xpovio  Selinexor 2019-7-3 Patient with relapsed/refractory multiple myeloma in adult 
15. Recarbrio  Imipenem, Cilastatin & Relebactam 2019-7-16 Complicated urinary tract & complicated intra abdominal infections
16. Accrufer Ferric maltol  2019-7-25 Iron deficiency anemia in adults 
17. Nubeqa Darolutamide  2019-7-30 Non metastatic castration resistant prostate cancer 
18. Turalio Pexidartinib 2019-8-2 Symptomatic tenosynovial giant cell tumor 
19. Pretomanid 2019-8-14 Multiple drug resistant tuberculosis
20. Wakix Pitolisant 2019-8-14 Excessive daytime sleepiness in adult with nacrolepsy
21. Rozlytrek Entrectinib  2019-8-15 Metastatic non small cell lung cancer whose tumors are RoS1 positive
22. Inrebic  Fedratinib 2019-8-16 Intermediate-2/high-risk primary/secondary myelofibrosis in adult
23. Rinvoq Upadacitinib 2019-8-16 Rheumatoid arthritis 
24. Xenleta Lefamulin 2019-8-19 Community acquired bacterial pneumonia 
25. Ga-68-DOTATOC Ga-68-DOTATOC 2019-8-21 Positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors  in adult & pediatric patients.
26. Nourianz Istradeflline  2019-8-27 Parkinson’s disease those experiencing ”off” episodes
27. Ibsrela Tenapanor 2019-9-12 Irritable bowel syndrome with constipation in adults
28. Aklief  Trifarotene 2019-10-4 Acne vulgaris in patients 9 years of age and older
29. Beovu Brolucizumab-dbll 2019-10-7 Wet age related macular degeneration 
30. Scenesse Afamelanotide  2019-10-8 Increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria
31. Fluorodopa F 18 2019-10-10 Visual detection of certain nerve cells in adult patients with suspected Parkinsonian Syndromes (PS)
32. Reyvow  Iasmiditan  2019-10-11 Acute migraine
33. Tikafta Elexacaftor/Ivacaftor/Tezacaftor 2019/10/21 Cystic fibrosis mutation
34. ExEm Foam Air polymer type A 2019-117 Diagnostic agent used to assess fallopian tube patency in women with known/suspected infertility 
35. Reblozyl  Luspatercept aamt 2019-11-8 Anemia in adults with lower-risk myelodysplastic syndromes
36. Brukinsa Zanubrutinib 2019-11-14 Treat adults with mantle cell lymphoma
37. Fetroja Cefiderocol 2019-11-14 Treat patients with complicated urinary tract infections who have limited/no alternative treatment options. including kidney infections caused by multidrug resistant gram negative microbes
38. Adakveo Crizanlizumab tmca 2019-11-15 Painful complication of sickle cell disease 
39. Givlaari Givosiran  2019-11-20 Acute hepatic porphyria
40. Xcopri Cenobamate 2019-11-21 Partial onset seizures 
41. Oxbryta Voxelotor  2019-11-25 Sickle cell disease
42. Vyondys 53 Golodirsen 2019-12-12 Duchenne Muscular dystrophy 
43. Padcev Enfortumabvedotin ejfv 2019-12-18 Refractory bladder cancer
44. TissueBlue Brilliant Blue G Ophthalmic solution 2019-12-20 Dye used in eye surgery
45. Caplyta Lumateperonetosylate 2019-12-20 Schizophrenia
46. Dayvigo Lemborexant 2019-12-20 Insomnia
47. Enhertu Fam transtuzumab deruxtecan nxki  2019-12-20 Metastatic breast 
48. Ubrelvy Ubrogepant 2019-12-23 For the acute treatment of migraine with or without aura in adults


CDER’s Annual Novel Drug Approvals: 2010 - 2019 In 2019, CDER approved 48 novel drugs. The 10-year graph below shows that from 2010 through 2018, CDER has averaged about 37 novel drug approvals per year.
CDER’s Annual Novel Drug Approvals: 2010 – 2019 In 2019, CDER approved 48 novel drugs. The 10-year graph below shows that from 2010 through 2018, CDER has averaged about 37 novel drug approvals per year.


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