Novel Drug Approvals for 2019
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, CDER provides scientific and regulatory advice needed to bring new therapies to market.
The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.
Each year, CDER approves a wide range of new drugs and biological products:
- Some of these products are innovative new products that never have been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2019. This listing does not contain 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.
- Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.
Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.
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 Press Release Drug Trials Snapshot |
47. | Enhertu | fam-trastuzumab deruxtecan-nxki | 12/20/2019 | To treat metastatic breast cancer Press Release Drug Trials Snapshot |
46 | Dayvigo |
lemborexant | 12/20/2019 | To treat insomnia Drug Trials Snapshot |
45. | Caplyta |
lumateperone tosylate | 12/20/2019 | To treat schizophrenia Drug Trials Snapshot |
44. | TissueBlue | Brilliant Blue G Ophthalmic Solution | 12/20/2019 | Dye used in eye surgery Drug Trials Snapshot |
43. | Padcev | enfortumab vedotin-ejfv | 12/18/2019 | To treat refractory bladder cancer Press Release Drug Trials Snapshot |
42. | Vyondys 53 | golodirsen | 12/12/2019 | To treat certain patients with Duchenne muscular dystrophy Press Release Drug Trials Snapshot |
41. | Oxbryta | voxelotor | 11/25/2019 | To treat sickle cell disease Press Release Drug Trials Snapshot |
40. | Xcopri | cenobamate | 11/21/2019 | To treat partial onset seizures Press Release Drug Trials Snapshot |
39. | Givlaari | givosiran | 11/20/2019 | To treat acute hepatic porphyria, a rare blood disorder Press Release Drug Trials Snapshot |
38. | Adakveo | crizanlizumab-tmca | 11/15/2019 | To treat patients with painful complication of sickle cell disease Press Release Drug Trials Snapshot |
37. | Fetroja | cefiderocol | 11/14/2019 | To treat patients with complicated urinary tract infections who have limited or no alternative treatment options Press Release Drug Trials Snapshot |
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 Drug Trials Snapshot |
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 Press Release Drug Trials Snapshot |
29. | Beovu | brolucizumab–dbll | 10/7/2019 | Treatment of wet age-related macular degeneration Drug Trials Snapshot |
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. Drug Trials Snapshot |
26. | Nourianz | istradefylline | 8/27/2019 | To treat adult patients with Parkinson’s disease experiencing “off” episodes Press Release Drug Trials Snapshot |
25. |
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 Press Release Drug Trials Snapshot |
23. | Rinvoq | upadacitinib | 8/16/2019 | To treat adults with moderately to severely active rheumatoid arthritis Drug Trials Snapshot |
22. | Inrebic | fedratinib | 8/16/2019 | To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis Press Release Drug Trials Snapshot |
21. | Rozlytrek | entrectinib | 8/15/2019 |
To treat adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive |
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 Press Release Drug Trials Snapshot |
17. | Nubeqa | darolutamide | 7/30/2019 | To treat adult patients with non-metastatic castration resistant prostate cancer Drug Trials Snapshot |
16. | Accrufer | ferric maltol | 7/25/2019 | To treat iron deficiency anemia in adults Drug Trials Snapshot |
15. | Recarbrio | imipenem, cilastatin and relebactam | 7/16/2019 | To treat complicated urinary tract and complicated intra-abdominal infections Press Release Drug Trials Snapshot |
14. | Xpovio | selinexor | 7/3/2019 | To treat adult patients with relapsed or refractory multiple myeloma (RRMM) Press Release Drug Trials Snapshot |
13. | Vyleesi | bremelanotide | 6/21/2018 | To treat hypoactive sexual desire disorder in premenopausal women. Press Release Drug Trials Snapshot |
12. | Polivy | polatuzumab vedotin-piiq | 6/10/2019 | To treat adult patients with relapsed or refractory diffuse large B-cell lymphoma Press Release Drug Trials Snapshot |
11. | Piqray | alpelisib | 5/24/2019 | To treat breast cancer Press Release Drug Trials Snapshot |
10. | Vyndaqel | tafamidis meglumine | 5/3/2019 | To treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults Press Release Drug Trials Snapshot |
9. | Skyrizi | risankizumab-rzaa | 4/23/2019 | To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Drug Trials Snapshot |
8. | Balversa | erdafitinib | 4/12/2019 | To treat adult patients with locally advanced or metastatic bladder cancer Press Release Drug Trials Snapshot |
7. | Evenity | romosozumab-aqqg | 4/9/2019 | To treat osteoporosis in postmenopausal women at high risk of fracture Press Release Drug Trials Snapshot |
6. | Mayzent | siponimod | 3/26/2019 | To treat adults with relapsing forms of multiple sclerosis Press Release Drug Trials Snapshot |
5. | Sunosi | solriamfetol | 3/20/2019 | To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea Drug Trials Snapshot |
4. | Zulresso | brexanolone | 3/19/2019 | To treat postpartum depression (PPD) in adult women Press Release Drug Trials Snapshot |
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” Drug Trials Snapshot |
2. | Cablivi | caplacizumab-yhdp | 2/6/2019 | To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) Press Release Drug Trials Snapshot |
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 |
*The listed “FDA-approved use” on this website is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, see the most recent FDA-approved Prescribing Information (click on the Drug Name).