FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance

On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will generally be the entire molecule, but it may also encompass noncovalent derivatives. Importantly, the active ingredient can take a different physical form than the active ingredient in the reference listed drug (RLD), and FDA will not consider this as relevant in determining sameness. FDA also noted that the active ingredient in a drug product “may undergo a change in chemical form during drug product manufacture such that the active ingredient is converted to a different chemical form.” In such cases, FDA considers the converted chemical form to be the active ingredient, and ANDA filers should use the converted form, as present in the final dosage of the RLD, for comparison when demonstrating sameness.

Read the full blog post.