Drugs

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, 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 IngredientApproval DateFDA-approved use on approval date
19.Zinplavabezlotoxumab10/21/2016To reduce the recurrence of Clostridium difficile infection in patients aged 18 years or older
Drug Trials Snapshot
18.Lartruvoolaratumab10/19/2016To treat adults with certain types of soft tissue sarcoma
Press Release 
Drug Trials Snapshot
17.Exondys 51eteplirsen9/19/2016To treat patients with Duchenne muscular dystrophy
Press Release
Drug Trials Snapshot
16.Adlyxinlixisenatide7/27/2016To improve glycemic control (blood sugar levels)
Press Release
15.Xiidralifitegrast ophthalmic solution7/11/2016To treat the signs and symptoms of dry eye disease
Press Release
Drug Trials Snapshot
14.Epclusasofosbuvir and velpatasvir6/28/2016To treat all six major forms of hepatitis C virus
Press Release
Drug Trials Snapshot
13.NETSPOTgallium Ga 68 dotatate6/1/2016A diagnostic imaging agent to detect rare neuroendocrine tumors
Press Release
Drug Trials Snapshot
12.Axuminfluciclovine F 185/27/2016A  new diagnostic imaging agent to detect recurrent prostate cancer
Press release
Drug Trials Snapshot
11.Ocalivaobeticholic acid5/27/2016To treat rare, chronic liver disease
Press release
Drug Trials Snapshot
10.Zinbrytadaclizumab5/27/2016To treat multiple sclerosis
Press Release
Drug Trials Snapshot
9.Tecentriqatezolizumab5/18/2016To treat urothelial carcinoma, the most common type of bladder cancer
Press Release
Drug Trial Snapshot
8.Nuplazidpimavanserin4/29/2016To treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease
Press Release
Drug Trial Snapshot
7.Venclextavenetoclax4/11/2016For chronic lymphocytic leukemia in patients with a specific chromosomal abnormality
Press Release
Drug Trials Snapshot
6.Defiteliodefibrotide sodium3/30/3016To 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.Cinqairreslizumab3/23/2016To treat severe asthma
Press Release
Drug Trials Snapshot
4.Taltzixekizumab3/22/2016To treat adults with moderate-to-severe plaque psoriasis. 
Press Release
Drug Trials Snapshot
3.Anthimobiltoxaximab3/18/2016To treat inhalational anthrax in combination with appropriate antibacterial drugs.
Press Release
Drug Trials Snapshot
2.Briviactbrivaracetam2/18/2016To treat partial onset seizures in patients age 16 years and older with epilepsy.
Press Release
Drug Trials Snapshot
1.Zepatierelbasvir and grazoprevir1/28/2016To treat patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.
Press Release
Drug Trials Snapshot

* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA).  For instance, new information may become available which could lead to a reconsideration of the original designation or status.  If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.

Page Last Updated: 11/29/2016
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