tentative approval
- Guideline or reference source
- FDA www.fda.gov
- Definition
- If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, 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.
- Broader Term
- approval
- Related Term
- tentative approval letter for an ANDA
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