Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn: Guidance for Industry

ucm510240.pdf

On July 11, 2016, the FDA published the draft guidance for industry entitled “Updating ANDA Labeling after the Marketing Application for the Reference Listed Drug (RLD) Has Been Withdrawn.”  This guidance describes a process to update labeling for abbreviated new drug applications (ANDAs) in cases where the FDA has withdrawn approval of the new drug application (NDA) for the ANDA’s reference listed drug (RLD) for reasons other than safety or effectiveness.

In general, all holders of marketing applications for drug products (both NDAs and ANDAs) have an ongoing obligation to ensure their product labeling is accurate, and not false or misleading.  When new information becomes available that causes the labeling to become inaccurate, false or misleading, the application holder must take steps to update its labeling.

Where approval of the NDA for the RLD has not been withdrawn, RLD holders often propose changes to the labeling by submitting them to the NDA.  ANDA holders are then expected to update their labeling after the FDA has approved relevant changes to the labeling for the corresponding NDA RLD.  However, when approval of an RLD is withdrawn, the NDA holder can no longer update the labeling for the withdrawn RLD.  Where approval of the NDA for the RLD has been withdrawn by the FDA for reasons other than safety or effectiveness, and ANDAs are pending or generic drugs continue to be marketed that rely on the withdrawn RLD, the labeling of those pending or marketed ANDA products may need to be updated to reflect changes that would have been necessary had the NDA for the RLD not been withdrawn. 

The FDA is publishing this guidance to advise industry on a process for updating the labeling for ANDAs that rely on an RLD for which approval has been withdrawn for reasons other than safety or effectiveness.  The guidance provides examples of updates considered appropriate under existing regulatory authorities.  This guidance will be of interest to the holders of pending or approved ANDAs that rely upon a withdrawn RLD, as well as to applicants seeking to submit ANDAs relying on RLDs for which approvals have been withdrawn for reasons other than safety or effectiveness.  The FDA anticipates that this guidance will help facilitate labeling updates for approved ANDAs as well as the approval of certain pending ANDAs where approval of the NDA for the RLD has been withdrawn. 

To comment on the draft guidance, please visit the public docket.