On September 28, 2020, FDA issued final guidance on amendments and requests for final approval to tentatively approved ANDAs. The guidance contains FDA’s nonbinding recommendations on the content and timing of amendments to tentatively approved ANDAs in order to obtain the earliest final approval possible.

Amendments to Tentatively Approved ANDAs

An ANDA that meets the substantive requirements for approval but cannot be approved due to unexpired patents or regulatory exclusivities will be tentatively approved. An applicant may submit an amendment to its tentatively approved ANDA, which will receive a review goal date consistent with the review goal dates outlined in the Generic Drug User Fee Amendments Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDFUA II Commitment Letter). If the earliest lawful approval date is not for several years, FDA may defer assessment of an amendment and the ANDA will remain tentatively approved. If FDA decides to assess the amendment, the ANDA status will change to under review.

Requests for Final Approval

Requests for final approval are considered amendments to the ANDA. As such, FDA does not automatically grant final approval when the patent or regulatory exclusivity barrier expires. Applicants are encouraged to file requests for final approval so that FDA has enough time to assess the amendment before the applicant’s desired approval date.

If an ANDA is granted tentative approval less than three years before the earliest lawful approval date, a request for final approval with no new information is considered a minor amendment and is usually assessed in three months. Requests with substantive changes will be classified as either minor or major amendments and are assigned a review goal date consistent with the classification. If an ANDA is granted tentative approval three years or more before the earliest lawful approval date, FDA may require a more extensive final review of the ANDA to consider any changes in FDA standards or procedures.

If the request for final approval has deficiencies that are not addressed by the Applicant during assessment, FDA will place the ANDA in complete response status until they are addressed. The final guidance contains a non-exhaustive list of common developments that may require amendments to the ANDA before requesting final approval.