FDA publishes revised MAPP, ANDA Suitability Petitions (5240.5)

Today, August 10, 2018, the FDA published a revision to the Manual of Policies and Procedures (MAPP 5240.5), “ ANDA Suitability Petitions.” This MAPP establishes the policies and procedures for responding to a suitability petition submitted to the FDA Office of Generic Drugs by or on behalf of a prospective abbreviated new drug application (ANDA) applicant. The MAPP was updated to reflect the current organization and processes of the generic drugs program. Certain differences between a reference listed drug (RLD) and a proposed generic drug product may be permitted in an ANDA if these differences are the subject of an approved suitability petition. An applicant may submit a suitability petition to the FDA under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and pursuant to 21 CFR 314.93 requesting permission to submit an ANDA for a generic drug product that differs from an RLD in its route of administration, dosage form, strength, or that has one different active ingredient in a fixed-combination drug. An ANDA citing a suitability petition that has not been approved will be refused for receipt because the application lacks a legal basis for the submission. Additional Resources: MAPP - https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/ CDER/ManualofPoliciesProcedures/UCM365676.pdf Suitability Petitions - https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedand Approved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm047676.htm#p4