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📄FDA Announces Draft Guidance for Roflumilast Bioequivalence

The Food and Drug Administration (FDA or Agency) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Roflumilast." The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for roflumilast topical cream.