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 |
|---|---|---|---|---|
| 9. | Tecentriq | atezolizumab | 5/18/2016 | To treat urothelial carcinoma, the most common type of bladder cancer Press Release |
| 8. | Nuplazid | pimavanserin | 4/29/2016 | To treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease Press Release |
| 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 | 3/30/3016 | 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 |
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