Product-Specific Guidances for Salmeterol Xinafoate and Fluticasone Propionate; Draft Guidances for Industry; Availability

Résumé

The Food and Drug Administration (FDA or Agency) is announcing the availability of three draft guidances for industry on generic salmeterol xinafoate inhalation powder, fluticasone propionate inhalation aerosol, and fluticasone propionate inhalation powder, entitled "Draft Guidance on Salmeteral Xinafoate" and "Draft Guidance on Fluticasone Propionate." The guidances, 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 salmeterol xinafoate inhalation powder, fluticasone propionate inhalation aerosol, and fluticasone propionate inhalation powder.