FDA Update

Not All Drugs Products Are Created Equally – PLEASE REVIEW THIS

FDA publishes draft guidance for industry: Sameness Evaluations in an ANDA – Active Ingredients

On November 8, 2022, FDA published a new draft guidance for industry entitled “Sameness Evaluations in an ANDA – Active Ingredients.”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.

FDA 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, 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, i.e., drug products with more than one active ingredient, the recommendations in this guidance apply to each active ingredient.

The guidance outlines general considerations for determining and characterizing the active ingredient in drug products, as well as considerations specific to synthetic peptides and complex mixtures.

FDA is issuing this guidance as part of our Drug Competition Action Plan, which seeks to improve the efficiency of the generic drug development, review, and approval process. An efficient generic drug review process helps to expand access to safe, high-quality, effective generic medicines that can, in turn, help consumers lower their health care costs.

Questions
For more information on the FDA process for ANDA please email us at: [email protected] and ref:. ANDA.