FDA publishes revised MAPP, Consolidation of ANDAs by the Office of Generic Drugs

The US FDA published a revision to the Manual of Policies and Procedures (MAPP 5241.2), “Consolidation of ANDAs by the Office of Generic Drugs.” This MAPP describes the process for reviewing and approving or denying requests to consolidate previously approved abbreviated new drug applications (ANDAs) submitted by an ANDA applicant. This MAPP applies to the Office of Generic Drugs’ (OGD) ANDA Consolidation Coordinator (ACC), who coordinates requests for consolidation, determines whether any of the ANDAs identified in the request for consolidation have associated open or outstanding issues, makes the consolidation determination, and ensures ANDAs are properly consolidated. This MAPP also applies to OGD regulatory project managers (RPMs), and Document Room staff who send consolidation requests to the OGD RPMs.

When appropriate, an ANDA applicant that owns several original ANDAs for different strengths of the same drug product may request consolidation of the ANDAs into one “parent” ANDA. Generally, the parent ANDA is the ANDA associated with the strength upon which all in vivo bioequivalence (BE) studies were conducted. Once the request is approved and the ANDAs are consolidated, the applicant may submit one prior approval supplement (PAS) or changes being effected (CBE) submission to the parent ANDA for any subsequent change to all strengths of the drug product and may submit any required postmarketing reports to one application.