U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
  5. Novel Drug Approvals for 2016
  1. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Novel Drug Approvals for 2016

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 2016. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2016 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.

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*
22. Spinraza nusinersen 12/23/2016 To treat children and adults with spinal muscular atrophy (SMA)
Press Release
Drug Trials Snapshot
21. Rubraca rucaparib 12/19/2016

To treat women with a certain type of ovarian cancer
Press Release 
Drug Trials Snapshot 

20. Eucrisa crisaborole 12/14/2016 To treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older
Press Release
Drug Trials Snapshot
19. Zinplava bezlotoxumab 10/21/2016 To reduce the recurrence of Clostridium difficile infection in patients aged 18 years or older
Drug Trials Snapshot
18. Lartruvo olaratumab 10/19/2016 To treat adults with certain types of soft tissue sarcoma
Press Release 
Drug Trials Snapshot
17. Exondys 51 eteplirsen 9/19/2016 To treat patients with Duchenne muscular dystrophy
Press Release
Drug Trials Snapshot
16. Adlyxin lixisenatide 7/27/2016 To improve glycemic control (blood sugar levels)
Press Release
Drug Trials Snapshot
15. Xiidra lifitegrast ophthalmic solution 7/11/2016 To treat the signs and symptoms of dry eye disease
Press Release
Drug Trials Snapshot
14. Epclusa sofosbuvir and velpatasvir 6/28/2016 To treat all six major forms of hepatitis C virus
Press Release
Drug Trials Snapshot
13. NETSPOT gallium Ga 68 dotatate 6/1/2016 A diagnostic imaging agent to detect rare neuroendocrine tumors
Press Release
Drug Trials Snapshot
12. Axumin fluciclovine F 18 5/27/2016 A  new diagnostic imaging agent to detect recurrent prostate cancer
Press release
Drug Trials Snapshot
11. Ocaliva obeticholic acid 5/27/2016 To treat rare, chronic liver disease
Press release
Drug Trials Snapshot
10. Zinbryta daclizumab 5/27/2016 To treat multiple sclerosis
Press Release
Drug Trials Snapshot
9. Tecentriq atezolizumab 5/18/2016 To treat urothelial carcinoma, the most common type of bladder cancer
Press Release
Drug Trials Snapshot
8. Nuplazid pimavanserin 4/29/2016 To treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease
Press Release
Drug Trials Snapshot
7. Venclexta venetoclax 4/11/2016 For chronic lymphocytic leukemia in patients with a specific chromosomal abnormality
Press Release
Drug Trials Snapshot
6. Defitelio defibrotide sodium 3/30/2016 To treat adults and children who develop hepatic veno-occlusive disease with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation
Press Release
Drug Trials Snapshot
5. Cinqair reslizumab 3/23/2016 To treat severe asthma
Press Release
Drug Trials Snapshot
4. Taltz ixekizumab 3/22/2016 To treat adults with moderate-to-severe plaque psoriasis. 
Press Release
Drug Trials Snapshot
3. Anthim obiltoxaximab 3/18/2016 To treat inhalational anthrax in combination with appropriate antibacterial drugs.
Press Release
Drug Trials Snapshot
2. Briviact brivaracetam 2/18/2016 To treat partial onset seizures in patients age 16 years and older with epilepsy.
Press Release
Drug Trials Snapshot
1. Zepatier elbasvir and grazoprevir 1/28/2016 To treat patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.
Press Release
Drug Trials Snapshot

*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).

 
Back to Top