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guidance describes a process for updating labeling for abbreviated new drug applications (ANDAs) in cases where FDA has withdrawn approval of the new drug application (NDA) for the ANDA’s reference listed drug (RLD) for reasons other than safety or effectiveness. Where approval of the NDA for the RLD has been withdrawn by FDA under these circumstances (referred to in this guidance as a “withdrawn RLD”), and ANDAs are pending or generic drugs continue to be marketed under one or more ANDAs that rely on the withdrawn RLD, the labeling of those pending or marketed ANDA products may need to be updated to reflect changes that would have been necessary had the NDA for the RLD not been withdrawn.
This guidance sets forth ways in which FDA may seek to facilitate the revision of labeling to reflect updated information for ANDAs that rely on withdrawn RLDs. This guidance will be of interest to the holders of pending or approved ANDAs that rely upon a withdrawn RLD, as well as to applicants seeking to submit ANDAs relying on withdrawn RLDs. We anticipate that this guidance will help facilitate labeling updates for approved ANDAs as well as the approval of certain pending ANDAs where the NDA for the RLD has been withdrawn.