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  4. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
  5. Novel Drug Approvals for 2019
  1. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

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
Press Release
Drug Trials Snapshot

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
Press Release
Drug Trials Snapshot

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
Press Release
Drug Trials Snapshot

32. Reyvow lasmiditan 10/11/2019

For the acute treatment of migraine with or without aura, in adults
Press Release
Drug Trials Snapshots

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)
Drug Trials Snapshot

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
Drug Trials Snapshot

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

Ga-68-DOTATOC

8/21/2019

For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs)
Drug Trials Snapshot

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
To treat adult and pediatric patients 12 years of age and older with solid tumors
Press Release
Drug Trials Snapshot: Pediatric patients 12 years of age and older with solid tumors
Drug Trials Snapshot: 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).