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USFDA Guidance: Navigating ANDA Submissions Latest Guidance on ANDA Amendments, Requests, and Labeling Revisions

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released two updated final guidances on 24 January 2024 "ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs" and "Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry".

An ANDA generally must contain information to show that the proposed generic product:

  1. is the same as the RLD with respect to the active ingredient(s), conditions of use, route of administration, dosage form, strength, and labeling (with certain permissible differences); and

  2. is bioequivalent to the RLD.

This guidance is designed to help applicants prepare and submit amendments to abbreviated new drug applications (ANDAs) that have been tentatively approved, including requests for final approval. It also provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections (“earliest lawful ANDA approval date”).

The FDA has identified common developments that could lead to an applicant making changes that should be submitted as an amendment to a tentatively approved ANDA before final approval is granted. In the cover letter of a request for final approval, all changes to the ANDA that have occurred since the TA was granted should be clearly noted.

As part of this guidance, applicants and holders of an abbreviated new drug application (ANDA) can update their labeling following revisions to the approved labeling of a reference listed drug (RLD). This guidance provides information on identifying updates to the RLD labeling and submitting amendments or supplements to update generic drug labeling.

Approved RLD labeling is revised by its application holder for a variety of reasons and is accomplished through the submission of information to the application under the appropriate reporting category. After the FDA has approved relevant changes to the labeling for the corresponding RLD, an ANDA holder should update its labeling.

Timely revising, submitting to the Agency, and implementing revised ANDA labeling are crucial to maintaining the safety and effectiveness of the generic drug consistent with the corresponding RLD.

To know more on how to obtain more information related to RLD labeling and how to submit revised labeling, click this LINK.


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