21 May 2025
📄FDA Announces Draft Guidance for Roflumilast Bioequivalence
Product-Specific Guidance on Roflumilast; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Roflumilast." The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
This regulatory notice announces a draft guidance for industry related to bioequivalence studies for roflumilast topical cream, impacting drug manufacturers' compliance and regulatory requirements. Businesses seeking to launch generic versions must align with these guidelines, potentially affecting product development timelines and costs.