FDA guidance for industry for ANDA submissions

The US Food and Drug Administration yesterday published the guidance for the pharmaceutical 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 the FDA’s final approval not being issued on the earliest lawful ANDA approval date.