*The listed “FDA-approved use” on this website is for presentation purposes only. To treat patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. To treat partial onset seizures in patients age 16 years and older with epilepsy. To treat inhalational anthrax in combination with appropriate antibacterial drugs. To treat adults with moderate-to-severe plaque psoriasis. 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 To treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s diseaseįor chronic lymphocytic leukemia in patients with a specific chromosomal abnormality To treat urothelial carcinoma, the most common type of bladder cancer To treat all six major forms of hepatitis C virusĪ diagnostic imaging agent to detect rare neuroendocrine tumorsĪ new diagnostic imaging agent to detect recurrent prostate cancer To treat the signs and symptoms of dry eye disease To improve glycemic control (blood sugar levels) To treat patients with Duchenne muscular dystrophy To treat adults with certain types of soft tissue sarcoma To reduce the recurrence of Clostridium difficile infection in patients aged 18 years or older To treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older To treat women with a certain type of ovarian cancer To treat children and adults with spinal muscular atrophy (SMA) 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. 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. 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. 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. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.Ĭertain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review.

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. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2016. Some of these products are innovative new products that never have been used in clinical practice.For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.Įach year, CDER approves a wide range of new drugs and biological products: The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. 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. 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.

Current week number 2016