48 New Drug FDA Approvals in 2019

Posted by Sierra Labs on Jan 10, 2020 12:45:25 PM

A comprehensive table of the 48 new drug approvals and their corresponding active ingredients, diseases, estimated sales, and companies.

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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!

 

48 New FDA Drug Approvals in 2019

Drug Name Approval Date Active ingredient Disease Peak Sales Estimate Company
1. Jeuveau Feb. 1, 2019 prabotulinumtoxinA-xfvs Frown lines $250 million in 2025

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2. Cablivi Feb. 6, 2019 caplacizumab-yhdp Acquired thrombotic thrombocytopenic purpura $500 million sanofi-aventis-logo-vector
3. Egaten Feb. 13, 2019 triclabendazole Fascioliasis (liver fluke infection) N/A 1280px-Novartis-Logo.svg
4. Zulresso March 19, 2019 brexanolone Postpartum depression $370 million 1200x620-1562670504495
5. Sunosi March 21, 2019 solriamfetol Sleepiness due to obstructive sleep apnea $500 million jazz_footer_logo
6. Mayzent March 26, 2019 siponimod Secondary progressive multiple sclerosis $1.3 billion 1280px-Novartis-Logo.svg
7. Evenity April 9, 2019 romosozumab Osteoporosis over $500 million Amgen%20Logo
8. Balversa April 12, 2019 erdafitinib Bladder cancer over $1 billion 1280px-JohnsonandJohnsonLogo.svg
9. Skyrizi April 23, 2019 risankizumab-rzaa Psoriasis, other inflammatory disorders $3 billion to $5 billion AbbVieLogo_Preferred_CoatedPMS
10. Vyndaqel May 3, 2019 tafamidis meglumine Transthyretin-mediated amyloidosis cardiomyopathy $1.5 billion Pfizer-Logo
11. Piqray May 27, 2019 alpelisib Breast cancer N/A 1280px-Novartis-Logo.svg
12. Polivy June 10, 2019 polatuzumab vedotin Diffuse large B-cell lymphoma $1 billion 1280px-Roche_Logo.svg
13. Vyleesi June 21, 2019 bremelanotide Hypoactive sexual desire disorder $170 million Amaq
14. Xpovio July 3, 2019 selinexor Relapsed or refractory multiple myeloma (RRMM) in adults N/A karyopharm-logo
15. Recarbrio July 17, 2019 imipenem, cilastatin, and relebactam Complicated UTIs and abdominal infections N/A 1280px-Merck_Logo.svg
16. Accrufer July 25, 2019 ferric maltol Iron deficiency anemia in adults N/A logo
17. Nubeqa July 30, 2019 darolutamide Prostate cancer €480 million to €1 billion exclusive_bayer_weborion-logo
18. Turalio Aug. 2, 2019 pexidartinib Tenosynovial giant cell tumor N/A Daiichi_Sankyo_logo_logotype
19. Pretomanid Aug. 14, 2019 pretomanid Drug-resistant tuberculosis N/A TB Alliance_PDP-model_mission-1
20. Wakix Aug. 15, 2019 pitolisant Narcolepsy N/A download
21. Rozlytrek Aug. 15, 2019 entrectinib ROS1-positive non-small cell lung cancer and NTRK fusion-positive tumors $700 million 1280px-Roche_Logo.svg
22. Inrebic Aug. 16, 2019 fedratinib Myelofibrosis $400 million

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23. Rinvoq Aug. 16, 2019 upadacitinib Rheumatoid arthritis $2.2 billion by 2023 AbbVieLogo_Preferred_CoatedPMS
24. Xenleta Aug. 19, 2019 lefamulin Community-acquired bacterial pneumonia N/A Nabriva_Logo
25. Ga 68 DOTATOC Aug. 21, 2019 Ga 68 DOTATOC Diagnostic agent for neuroendocrine tumors N/A ui-hospitals-and-clinics-logo(PET Imaging)
26. Nourianz Aug. 27, 2019 istradefylline Parkinson’s disease N/A h-kyowakirin
27. Ibsrela Sept. 12, 2019 tenapanor Irritable bowel syndrome with constipation N/A Ardelyx
28. Aklief Oct. 4, 2019 trifarotene Acne N/A logo
29. Beovu Oct. 8, 2019 brolucizumab Wet age-related macular degeneration $1 billion 1280px-Novartis-Logo.svg
30. Scenesse Oct. 9, 2019 afamelanotide Erythropoietic protoporphyria N/A clinuvel-logo
31. Fluorodopa F 18 Oct. 10, 2019 fluorodopa F 18 Diagnostic agent for Parkinsonian syndromes N/A

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32. Reyvow Oct. 11, 2019 lasmiditan Migraine ~$500 million 1200px-Eli_Lilly_and_Company.svg
33. Trikafta Oct. 21, 2019 elexacaftor/ivacaftor/tezacaftor Cystic fibrosis $6.6 billion by 2025 1200px-Vertex_logo.svg
34. ExEm Foam Nov. 7, 2019 air polymer-type A Assess fallopian tube patency (openness) in women with known or suspected infertility  N/A Screen Shot 2020-01-09 at 10.19.43 PM copy
35. Reblozyl Nov. 8, 2019 luspatercept–aamt Anemia in patients with beta thalassemia $2 billion 873px-Celgene_logo.svgPNGPIX-COM-Bristol-Myers-Squibb-Logo-PNG-Transparentlogo-acceleron
36. Brukinsa Nov. 14, 2019 zanubrutinib Mantle cell lymphoma $2.2 billion (2025) ded483c0f261a95d7df8bdd3f35f
37. Fetroja Nov. 15, 2019 cefiderocol Urinary tract infections N/A SHIONOGI-LOGO
38. Adakveo Nov. 15, 2019 crizanlizumab Sickle cell disease over $1 billion 1280px-Novartis-Logo.svg
39. Givlaari Nov. 20, 2019 givosiran Acute hepatic porphyria $500 million Logo_Alnylam_460-1
40. Xcopri Nov. 21, 2019 cenobamate Partial-onset adult seizures $840 million SKLifelogo_1570708720595-HR
41. Oxbryta Nov. 25, 2019 voxelotor Sickle cell disease $2.5 billion logo
42. Vyondys 53 Dec. 12, 2019 golodirsen Duchenne muscular dystrophy $220 million sarepta
43. Padcev Dec. 18, 2019 enfortumab vedotin Metastatic bladder cancer >$5 billion Seattle_Genetics_logo1280px-Astellas_logo.svg
44. TissueBlue Dec. 20, 2019 Brilliant Blue G Ophthalmic Solution Dye used in eye surgery N/A plfztgxsqfw0k8bvjrcu
45. Caplyta Dec. 20, 2019 lumateperone tosylate Schizophrenia $60 million in 2020, $400 million by 2024 Intra-Cellular-Logo
46. Dayvigo Dec. 20, 2019 lemborexant Insomnia $1.1 billion logo-one-300x180
47. Enhertu Dec. 20, 2019 fam-trastuzumab deruxtecan-nxki HER2-positive breast cancer $2.5 billion logo-az.png.pagespeed.ce.skm4LfcU13Daiichi_Sankyo_logo_logotype
48. Ubrelvy Dec. 23, 2019 ubrogepant Migraine $302 million primary_fullcolor

 

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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.

Topics: FDA, Compliance, CDER, New Drugs, Center for Drug Evaluation and Research, Drug Approval, FDA Approval

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