ANDA consolidation process updated in new MAPP

Regulatory NewsRegulatory News | 21 August 2020 |  By 

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.
Once the consolidation has been approved and effected, sponsors may then submit just one prior approval supplement or one changes being effected submission under the parent ANDA for a desired change to the strength of the drug product. Additionally, all postmarketing reports can then be submitted to the parent ANDA application.
The MAPP’s revision provides an updated workflow for the consolidation review process under the ANDA Consolidation Coordinator at the Office of Generic Drugs (OGD). This position “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,” according to FDA’s announcement of the update.  The roles of OGD regulatory project managers and document room staff are also spelled out in the updates.


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Tags: FDA, generics, US

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