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.
Keynotes about USFDA tentative approval:
- A tentative approval does not allow the applicant to market the generic drug product.
- Tentative approval is granted by the FDA if an ANDA meets the substantive requirements for approval but cannot obtain final approval due to unexpired patents or exclusivities.
- To gain final approval, applicants may submit changes to the application, request final approval, or propose changes and request final approval through amendments. The nature of these amendments may delay final approval of the ANDA until after the earliest lawful ANDA approval date. A drug product may not be marketed until the ANDA gains final Agency approval.
Requesting Final Approval for Tentatively Approved ANDAs
- When an amendment is submitted to a tentatively approved ANDA, FDA has the option to assess the amendment or defer it. If the Agency decides to assess the amendment, the status of the submitted ANDA will be changed from “TA” to “under review”.
- After review, if the ANDA meets all requirements for final approval, approval will be granted by the Agency.
- If the amendment has not resolved all deficiencies, the status of the ANDA will be converted to a complete response status as communicated in the complete response letter (CRL). The complete response status will remain in effect until the deficiencies are addressed in a subsequent amendment and FDA reinstates TA or grants final approval.