Sameness evaluations in an ANDA – FDA guidance

The US Food and Drug Administration (FDA) yesterday published a new draft guidance for industry, titled “ Sameness Evaluations in an ANDA – Active Ingredients.”

The guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug (RLD) as required under the Federal Food, Drug, and Cosmetic Act.

The FDA said it will refuse to approve an ANDA if it contains insufficient information to show that, among other things, the active ingredient of the proposed generic drug product is the same as that of the RLD. Accordingly, it noted, the ANDA applicant is responsible for providing sufficient information to demonstrate that the proposed generic drug product is the “same as” the RLD with respect to the active ingredient. For fixed-combination drug products, ie, drug products with more than one active ingredient, the recommendations in this guidance apply to each active ingredient.