May 14, 2019
Authored and Edited by Megan L. Meyers; Shana K. Cyr, Ph.D.
On May 9, 2019, FDA issued final guidance titled, “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” FDA intends the guidance to assist applicants in determining which abbreviated approval pathway is appropriate when filing a drug marketing application. The final guidance is nearly identical to FDA’s draft guidance of the same name from October 2017. Finnegan’s IP FDA Blog post on the draft guidance can be found here.
The guidance draws various comparisons between ANDAs and 505(b)(2) applications. For example, an ANDA applicant must demonstrate that the proposed generic product is therapeutically equivalent to the applicable RLD, while a 505(b)(2) applicant need not demonstrate this. An ANDA applicant must also show that the proposed generic drug product and RLD are the same with respect to their active ingredient(s), dosage form, route of administration, strength, conditions of use, and labeling (with certain exceptions), while this is not required for a 505(b)(2) application. Additionally, an ANDA relies on FDA’s findings of safety and effectiveness for an RLD, while a 505(b)(2) application may rely on FDA’s findings of safety and/or effectiveness for a listed drug only to the extent the proposed product shares characteristics with it (e.g., active ingredient, dosage form, route of administration, strength, indication or other conditions of use). To the extent a 505(b)(2) drug and a listed drug differ (e.g., a product with a different dosage form), the 505(b)(2) application must support the differences with sufficient data, such as clinical investigations.
FDA provides three regulatory considerations when deciding whether to file an ANDA or 505(b)(2) application:
FDA also provides three scientific considerations:
Readers are encouraged to read the final guidance, also available on FDA’s website.
drugs, Food and Drug Administration (FDA), FDA Guidance, generic drug, 505(b)(2) application, 2019 Top Insights
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