Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Drugs

October 3: Can you explain what is meant by tentative approval?

CDER Director

If a generic drug product application is submitted for approval before the expiration of any patents or exclusivities granted to the original, brand-name product, FDA issues a tentative approval letter to the applicant. The tentative approval letter delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. A product that has tentative approval cannot be marketed or sold in the United States.

Related Information

Page Last Updated: 02/26/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.