Novel Drug Approvals at FDA

What are "Novel" Drugs?

"Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products. 

Helping Guide the Way for New Medicines

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. 

A Wie Range of Products

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 approved by CDER and organized by calendar year. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved 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. See Drugs@FDA for information about all of CDER’s approved drugs and biological products. 

New Molecular Entity and New Therapeutic Biological Product Approvals (CDER only): Novel Drug Approvals for 2024

Drug Approval Information (CDER only): Recent New and Generic Drug Approvals

Source from FDA

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