About the FDA Approved Listings

The criteria for CenterWatch's FDA Approval Listings follow the definitions set forth by the Tufts Center for the Study of Drug Development and the FDA definitions of a new drug approval or a new molecular entity.

Our "Drugs Approved by the FDA" listings include:

New Molecular Entities (NME), defined by the FDA as a medication containing an active substance that has never before been approved for marketing in any form in the United States. The listing also includes some recombinant proteins and biologics that were approved by the FDA's Center for Drug Evaluation and Research (CDER).

The listings do NOT include:

Diagnostic agents, generics, over-the-counter products, medical devices, biologic compounds not approved by CDER and most vaccines. We also exclude new dosages, new indications and new administrations of previously-approved compounds.