Suitability Petitions for ANDAs

An ANDA suitability petition is a petition (request) to FDA to permit the filing of an ANDA for a drug that differs from the RLD.  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  (e.g., change from tablet to capsule),  strength, (Congress permitted this type of change but, since the passage of Hatch-Waxman and the advent of the petition process, FDA has not approved this type of change to date because it almost always raises some question of safety or efficacy.) 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. The Food and Drug Administration (FDA) will approve a suitability petition unless, among other reasons, one of the following occurs: 1.            FDA determines that the safety and effectiveness of the proposed change from the reference listed drug (RLD) cannot be adequately evaluated without data from investigations that would be beyond the scope of what may be required for an ANDA. 2.         A drug product is approved in a new drug application for the change requested in the suitability petition. 3.      The suitability petition requests changes to a drug product that trigger the need for pediatric studies under the Pediatric Research Equity Act (Public Law 108-155) to assess the safety and efficacy of that drug product in a relevant pediatric subpopulation that would not be waived by FDA, which renders the proposed product ineligible for approval in an ANDA. 1 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. FDA’s office of generic drugs (OGD) is responsible for review of suitability petition requests. FDA’s will approve or deny an ANDA suitability petition no later than 90 days after its submission.

Key Words

ANDA Suitability Petitions/ Petitioned ANDA