8 Aug 2025
💉FDA Draft Guidance on Iron Sucrose and Bioequivalence for Industry
Product-Specific Guidance on Iron Sucrose; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry entitled "Draft Guidance on Iron Sucrose." This revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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 iron sucrose intravenous injectable.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's draft guidance on iron sucrose pertains to product-specific recommendations for bioequivalence studies, impacting businesses involved in drug production, especially generic manufacturers. Compliance with the finalized guidance will be crucial for obtaining abbreviated new drug applications (ANDAs).