Regulatory Uncategorized

Revising ANDA Labeling Following Revision of the RLD Labeling

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Revising abbreviated new drug applications (ANDAs) Labeling Following Revision of the reference listed drugs (RLDs).”

In this guidance, FDA is providing information on

  • How ANDA applicants and holders should monitor for changes to RLD labeling:

    The sponsor of an ANDA should routinely monitor the Labeling Review Branch Homepage for information on changes in labeling as Office of Generic Drugs Labeling Review Branch will place monthly updates of approved labeling changes for RLDs with approved ANDAs on the Labeling Review Branch Homepage at:

  • How to submit revised labeling:

    All ANDA labeling changes needed because of approved changes to the labeling of the RLD may be submitted as a Special Supplement – Changes Being Effected. Such supplements should include:

    • 12 copies of final printed labeling.
    • The date the revised labeling will be used (go into effect).
    • A side-by-side comparison of the ANDA labeling with the approved labeling of the RLD with all differences annotated and explained, as described in 21 CFR 314.94 (a)(8)(iv)
  • This guidance revises the guidance for industry entitled ‘‘Revising ANDA Labeling Following Revision of the RLD Labeling’’ issued in April 2000. For more detail refer: