New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) provides clarity to drug developers on the necessary study design elements and other data needed in the drug application to support a full and comprehensive assessment. To do so, CDER relies on 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.
Each year, CDER approves a wide range of new drugs and biological products:
- Some of these products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products that CDER approved in 2022. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2022.
- Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.
Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that FDA had not previously approved, 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 FDA has previously approved. 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.
New Molecular Entity and New Therapeutic Biological Product Approvals (CDER only)
- Novel Drug Approvals for 2021
- Novel Drug Approvals for 2020
- Novel Drug Approvals for 2019
- Novel Drug Approvals for 2018
- Novel Drug Approvals for 2017
- Novel Drug Approvals for 2016
- Novel Drug Approvals for 2015
Drug Approval Information (CDER only)
- Recent New and Generic Drug Approvals
- Drug Approval Reports by Month
- Drug and Biologic Approval and IND Activity Reports
Related Information from Other FDA Centers
Resources For You
- Prescribing Information Resources
- Frequently Asked Questions: Breakthrough Therapies
- Critical Path Innovation Meetings (CPIM)