Earlier today (November 8, 2022) USFDAs Center for Drug Evaluation and Research, Office of Generic Drugs released a Draft guideline on "Sameness Evaluations in an ANDA — Active Ingredients".
As part of our Drug Competition Action Plan, FDA is issuing this guidance to improve generic drug development, review, and approval.
The guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by providing recommendations on how to demonstrate the sameness between the active ingredient in the proposed generic drug product and its reference listed drug (RLD) as required under the Federal Food, Drug, and Cosmetic Act.
An ANDA will not be approved if it does not contain adequate information showing that, among other things, the active ingredient of the proposed generic drug is identical to that of the reference generic drug. Therefore, the ANDA applicant must provide enough information to demonstrate that the proposed generic drug product is equivalent to the RLD in terms of active ingredient.
In addition to general considerations, the guidance describes particular considerations for synthetic peptides and complex mixtures, as well as general considerations for determining the active ingredient in drug products.
Click this LINK to know more about the Characterization of the Active Ingredient, Active Ingredient Sameness Considerations in Certain Drug Products, etc.
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