Suitability Petitions
Certain differences between a reference listed drug (RLD) and a proposed generic drug product may be permitted in an abbreviated new drug application (ANDA) if these differences are the subject of an approved suitability petition submitted under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, and pursuant to 21 CFR 314.93.
An applicant may submit a suitability petition to the FDA 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
- if it has one different active ingredient in a fixed-combination drug product.
An ANDA citing a suitability petition that has not been approved will not be received for review because the application lacks a legal basis for the submission.
A generic applicant cannot submit an ANDA for such a product until FDA has approved the related petition. The grounds for FDA approval of such a petition are set out in 21 CFR 314.93(e). The determination that an ANDA will be approved is not made until the ANDA itself is submitted and is reviewed by the Agency.