ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs | FDA

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs | FDA

Guidance for Industry: ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

On September 28, 2020, the FDA published the guidance for industry entitled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs.” This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. This guidance also provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion that can result in final approval on the earliest lawful approval date.

An ANDA applicant may submit amendments to a tentatively approved application that propose changes to the application and/or request final approval. As described in the guidance, a delay in submitting an amendment, or submitting an amendment that contains changes, could result in FDA’s final approval not being issued on the earliest lawful ANDA approval date.

FDA’s Drug Competition Action Plan aims to encourage innovation in drug development and accelerate the public availability of safe, high quality, lower-cost medications. This guidance offers applicants with tentatively approved ANDAs recommendations to avoid delays in obtaining the final approval of their ANDA and may, in turn, help increase the number of affordable medicines on the market.

Additional resources:

• Direct link to guidance – https://www.fda.gov/regulatory-information/search-fda-guidance-documents/anda-submissions-amendments-and-requests-final-approval-tentatively-approved-andas