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GUIDANCE DOCUMENT

Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry July 2016

Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance describes a process for updating labeling for abbreviated new drug applications (ANDAs) in cases where FDA has withdrawn approval of the new drug application (NDA) for the ANDA’s reference listed drug (RLD) for reasons other than safety or effectiveness. Where approval of the NDA for the RLD has been withdrawn by FDA under these circumstances (referred to in this guidance as a “withdrawn RLD”), and ANDAs are pending or generic drugs continue to be marketed under one or more ANDAs that rely on the withdrawn RLD, the labeling of those pending or marketed ANDA products may need to be updated to reflect changes that would have been necessary had the NDA for the RLD not been withdrawn.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.