💊FDA Draft Guidance on Fluticasone Propionate Impacting Generic Drugs
Product-Specific Guidance on Fluticasone Propionate; Draft Guidance for Industry; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Fluticasone Propionate." The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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 fluticasone propionate nasal spray, metered.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The draft guidance by the FDA provides crucial bioequivalence recommendations for fluticasone propionate nasal spray, affecting compliance for businesses developing generic drugs. Since this impacts regulatory requirements and product development strategies, it holds significant relevance for pharmaceutical executives.