FDA publishes draft guidance for industry: ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

On January 16, 2019, the FDA published the draft guidance for industry entitled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs.” This draft guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests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, request final approval, or propose changes and request final approval. As described in the draft guidance, a delay in submitting an amendment, or submitting an amendment that contains changes, could result in FDA’s final approval not being issued on the earliest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. In particular, applicants that wish to request final approval should determine whether changes to their ANDA are necessary before requesting this final approval, review any changes that have been made since the tentative approval was granted, and consider the possible review goal dates that may be assigned to the request for final approval to request final approval in a timely fashion. 

The FDA’s Drug Competition Action Plan aims to encourage innovation in drug development and accelerate the public availability of safe, high quality, lower cost alternatives to innovator medicines. This draft guidance offers applicants with tentatively approved ANDAs recommendations for preparing and submitting amendments to these ANDAs, including requests for final approval. These recommendations can help such applicants avoid delays in obtaining the final approval of their ANDA, and may in turn help increase the number of affordable medicines on the market.

We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document. This posting is to provide advance notice to the public. When publication in the FR becomes available, a notice will be available in the FR which will also detail how to submit comments on this document.

Direct link to the guidance: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM629489.pdf

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