July 8, 2016
Authored and Edited by Megan Leinen Johns; M. Andrew Holtman, Ph.D.
In July 2016, FDA released nonbinding draft Guidance for Industry, Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn. The Guidance describes a process for updating generic-drug labels when the FDA withdraws approval of the NDA for the RLD. For RLDs discontinued from marketing but where the NDA has not been withdrawn, the NDA holder remains responsible for keeping labeling up-to-date. The FDA clarifies here that for withdrawn RLDs, certain ANDA labeling changes may be needed. For instance, for ANDAs relying on RLD NDAs that have been withdrawn for reasons other than safety or effectiveness, the NDA holder no longer has a duty to update its label. Thus, there remains the possibility of generic labeling becoming inaccurate and outdated to the point of containing false and/or misleading information. With this Guidance, ANDA holders can provide labeling updates by submitting a Prior Approval Supplement (PAS), and FDA can request other ANDA holders to make the same updates if appropriate and may also request a Changes Being Effected (CBE-0) supplement if it becomes aware of needed labeling updates.
ANDAs holders for withdrawn RLDs should seek to update labels with relevant non-product specific literature and post-marketing data, as well as data from updated labeling of other drugs in the same pharmacologic or therapeutic class. Consistency with product labeling for the same API, APIs in the same pharmacologic or therapeutic class, or for other APIs approved for the same indication should be considered. FDA provides a non-exhaustive list of contemplated updates, including updating (1) indications to reflect current disease terminology or to modify outdated use restrictions; (2) required statements about systemic antimicrobial resistance; (3) required statements for visual inspection of parenteral products; (4) contradictions to remove risks if the benefit outweighs them; (5) warnings and precautions to include current steps regarding a clinically significant adverse reaction or risk; (6) to include a new adverse reaction; (7) to include recommended statements regarding adverse reactions from spontaneous reports; (8) to include new clinically significant drug interactions; (9) overdose management strategies as per Poison Control recommendations; (10) susceptibility test information for systemic antibacterial drugs; (11) as per current class Medication Guides; (12) as per FDA requests prior to RLD withdrawal; and (13) as per FDA regulations, guidance, or Federal Register notices even if they do not specifically address withdrawn RLDs.
United States Court of Appeals for the Federal Circuit (CAFC), Food and Drug Administration (FDA), FDA Guidance, generic drug, drugs, 505(b)(2) application, new drug application (NDA)
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