FDA publishes revised MAPP, ANDA Suitability Petitions (MAPP 5240.5)

[CATEGORY]

On October 9, 2020, FDA published a revision to the Manual of Policies and Procedures (MAPP 5240.5), “ANDA Suitability Petitions.” This MAPP describes the policies and procedures of the Office of Generic Drugs (OGD) for responding to suitability petitions submitted to it by or on behalf of prospective abbreviated new drug application (ANDA) applicants. FDA revised this MAPP to reflect and clarify current policies and procedures.

A prospective applicant may submit a petition to FDA requesting permission to submit an ANDA for a generic drug product that differs from a reference listed drug (RLD) in its route of administration, dosage form, or strength, or that has one different active ingredient in a fixed-combination drug product (i.e., a drug product with multiple active ingredients).

The FDA will approve a suitability petition unless, among other reasons, one of the following occurs:

• FDA determines that the safety and effectiveness of the proposed change from the RLD cannot be adequately evaluated without data from investigations that would be beyond the scope of what may be required for an ANDA.
• A drug product is approved in a new drug application (NDA) for the change requested in the suitability petition.
• The suitability petition requests changes to a drug product that trigger the need for pediatric studies under the Pediatric Research Equity Act.

FDA will refuse to receive an ANDA citing to a pending suitability petition (or to a suitability petition that was denied) because that ANDA would lack a legal basis for submission.

For full details, please view the MAPP at https://www.fda.gov/media/86656/download.