Topical Dermatologic Corticosteroids: In Vivo Bioequivalence; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Topical Dermatologic Corticosteroids: In Vivo Bioequivalence." This guidance provides recommendations to applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroids of all potency groups (referred to in this notice as topical corticosteroids). The guidance describes recommendations for an in vivo pharmacodynamic approach to demonstrate the bioequivalence (BE) of topical corticosteroids. This guidance provides clarity for potential ANDA applicants on the appropriate pilot dose duration vasoconstrictor response and pivotal vasoconstrictor BE studies and other recommendations for pharmacodynamic approaches to assess the BE of topical corticosteroids. This guidance finalizes the draft guidance of the same title "Topical Dermatologic Corticosteroids: In Vivo Bioequivalence" issued on October 24, 2022, and replaces the guidance for industry of the same title issued on June 2, 1995.