USA – ANDA consolidation process updated in new MAPP

The US Food and Drug Administration (FDA) has updated its manual of policies and procedures (MAPP) for the review of requests to consolidate previously approved generic drug applications.
 
The revised MAPP, entitled “Consolidation of ANDAs by the Office of Generic Drugs,” replaces the original October 2015 version of the document. The revisions clarify the process for sponsors of Abbreviated New Drug Applications (ANDAs) who wish to consolidate several ANDAs for different strengths of the same drug into a single “parent” ANDA. Which ANDA becomes the parent is generally determined by which drug product strength was used for bioequivalence studies…