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U.S. Department of Health and Human Services

Drugs

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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.

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