When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance

Posted 12 October 2017 By Zachary Brennan

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The US Food and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted.

The draft highlights criteria for submitting ANDAs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), petitioned ANDAs under section 505(j)(2)(C) of the FD&C Act, or new drug applications (NDAs) pursuant to section 505(b)(2) of the FD&C Act. The guidance features considerations to help potential applicants determine which pathway would be appropriate.

At the outset, FDA defines the various applications, noting that an ANDA is for a duplicate of a previously approved drug that relies on FDA’s finding that the reference listed drug (RLD) is safe and effective. In contrast, a petitioned ANDA is a type of ANDA for a drug product that differs from the RLD in its dosage form, route of administration, strength or active ingredient and for which FDA has determined, in response to a suitability petition, that studies are not necessary to establish the safety and effectiveness of the proposed drug product.

Meanwhile, a 505(b)(2) application is an NDA that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use.

Submissions of 505(b)(2) applications and ANDAs have seen increases in recent years, with many follow-on insulins submitted under the 505(b)(2) pathway and a record number of ANDAs submitted and approved as generic drugs.

Regulatory and Scientific Considerations

The guidance focuses on several topics in terms of regulatory considerations, including:

  • Duplicates: FDA generally will refuse to file a 505(b)(2) application for a drug that is a duplicate of a listed drug
  • Petitioned ANDAs and the criteria under which FDA will approve a suitability petition;
  • Bundling: when applicants seek approval for multiple drugs containing the same active ingredient(s) when some of these products would qualify as an ANDA and some would qualify for approval under the 505(b)(2) pathway.

In addition, FDA discusses scientific considerations for ANDAs and 505(b)(2) applications in cases where there are limited confirmatory studies, when there are questions about determining active ingredient sameness, when there are intentional differences in formulation, labeling, conditions of use, bioequivalence and/or bioavailability and other differences between the proposed drug and the RLD.

The draft, which explains how to reach out to FDA, also offers a couple of examples and explanations for formulation differences for parenteral drugs, ophthalmic drugs and otic drugs.

Determining Whether to Submit an ANDA or a 505(b)(2) Application: Draft Guidance for Industry

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Tags: 505(b)(2) application, ANDA, FDA draft guidance

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