The FDA has issued a draft guidance on bioequivalence recommendations for generic fluticasone propionate/salmeterol xinafoate inhalers. Notice of the draft guidance appeared in the Federal Register for September 10, 2013.
According to the agency, public responses to the draft guidance will be considered before the agency responds to a December 2009 citizen petition from Advair Diskus manufacturer GlaxoSmithKline “requesting that FDA withhold approval of any ANDA or 505(b)(2) application for generic oral inhalation products containing fluticasone propionate and/or salmeterol xinafoate unless certain conditions were satisfied, including conditions related to demonstrating BE (Docket No. FDA–2009–P–0597).” No ANDAs are currently approved for generic versions of Advair Diskus.
The FDA specifies that “The draft guidance, when finalized, will represent the Agency’s current thinking on the design of BE studies to support ANDAs for fluticasone propionate; salmeterol xinafoate. . . . An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulation.”
View the draft guidance.
Read the notice in the Federal Register.
