Health Law Daily Draft guidance clarifies process for amending tentatively approved ANDAs
Friday, February 1, 2019

Draft guidance clarifies process for amending tentatively approved ANDAs

By Rebecca Mayo, J.D.

A new draft guidance was issued to assist ANDA applicants in preparing and submitting amendments to tentatively approved ANDAs in a timely fashion to obtain final approval on the earliest lawful approval date.

The FDA has issued a new draft guidance intended clarify the process for preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. The new draft guidance explains how applicants should determine when they should submit amendments in order to allow the FDA enough time to process the amendment before the earlier state lawful approval date. It also includes information about what changes applicants should be watching for after an application is tentatively approved, and what should be included in the amendment (Notice, 84 FR 1164, February 1, 2019).

Tentative approval. An ANDA receives tentative approval if it meets the substantive requirements for approval but cannot be finally approved because of unexpired patents or exclusivities. An ANDA applicant may submit amendments to a tentatively approved application that propose changes to the application, request final approval, or propose changes and request final approval. The ANDA applicant should review the Generic Drug User Fee Amendments Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018–2022 to determine the review goal dates for different amendment types so an amendment may be timely submitted.

Requests for final approval. A tentatively approved ANDA is not automatically granted final approval upon the expiration of any periods of exclusivity or patent protection that served as the basis of the tentative approval. The ANDA applicant must submit an amendment to its ANDA explicitly requesting final approval to market its drug. Since the tentative approval is based on information available to the FDA at the time of the original tentative approval, it is necessary for the ANDA applicant to monitor for updates related to the applicant’s drug product and ensure that amendments addressing these updates are timely submitted to and are clearly identified for the FDA either before a request for final approval or in the request for final approval, permitting FDA sufficient assessment time to meet the ANDA’s earliest lawful approval date.

Changes that may impact approval. The FDA identified common developments that may require an applicant to make changes that should be submitted in an amendment to its tentatively approved ANDA before final approval is granted. The draft guidance includes a non-exhaustive list of those common developments which includes a list of product quality updates, bioequivalence updates, labeling updates, as well as orange book listing, patent, and exclusivity updates. The FDA recommends that the request for final approval indicate if there has been no change, if there is an editorial or other nonsubstantive change, if there is substantive new information, or if the labeling for the proposed drug product has changed. The request should also include a statement indicating whether the request should be considered major or minor.

Timing. If an ANDA received a tentative approval less than three years before the earliest lawful approval date, an amendment should be submitted with enough time to permit the FDA to assess the amendment before the date on which the applicant seeks approval. If no new data, information, or other changes to the ANDA are being submitted, the amendment is considered minor and should be submitted no later than three months before the date on which the applicant is seeking final approval. If the request for final approval contains substantive changes, it may be classified as either major or minor and a review goal date that corresponds with that classification will be assigned. Therefore, the applicant should review the goal dates as described above to determine when the amendment should be submitted to allow FDA enough time to complete its review.

If an ANDA has been in tentative approval statutes for three years or more before the earliest lawful approval date, a more extensive assessment before final approval may be necessary. If applicable product-specific guidance for the ANDA have been revised, manufacturing standards have been changed, or significant RLD labeling changes have been approved, the amendment should be submitted as a major amendment 10 months before the earliest lawful approval date.

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