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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, FDA 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 before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.

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
27. Ibsrela tenapanor 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
Press Release
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