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FDA published a new guidance in support of Drug Competition Action Plan, named “Revising ANDA Labeling Following Revision of the RLD Labeling”, providing the recommendations to tentatively approved ANDAs to help facilitate final approval on the earliest lawful approval date.

The guidance is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling following revisions to the approved labeling of a reference listed drug (RLD). This guidance provides recommendations on identifying RLD labeling updates and submitting ANDA amendments or supplements to update generic drug labeling.

The guidance provides clear expectations for when updates to labeling are required, the process for updating labeling, and the types of submissions for labeling updates.

The submission should include the below

Such submissions should include:

  • Form FDA 356h
  • Cover letter
  • Patent and exclusivity statement in cover letter and/or eCTD submission
  • Revised labeling
  • A side-by-side comparison of the proposed ANDA labeling with the approved labeling of the RLD with all differences annotated and explained
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