Tentative Drug Approval
If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference list drug product (an approved drug product to which new generic versions are compared), FDA issues a tentative approval letter to the applicant. The tentative approval letter details the circumstances associated with the tentative approval. FDA delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. A tentative approval does not allow the applicant to market the generic drug product in the United States. (DAIDS)
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