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/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm047676.htm#p4