FDA REBUFFS CONCERNS FOR GENERIC FLONASE

In approving the first generic version ofGlaxoSmithKline's allergy drug Flonase,FDA officials rejected bioequivalence concernsraised in several citizen petitionsthat questioned the approval criteria forthat drug. After considering the issuesraised by those petitioners, FDA officialsstressed that generic drug applicationsare subject to "the same thorough andrigorously scientific review for safety,effectiveness, and quality as the applicationsfor new (branded) drugs."

According to the FDA, "consumers andhealth professionals can be assured thatan approved generic drug is bioequivalentto a brand name drug and is its equal indosage form, strength, route of administration,quality, performance characteristics,and intended use." The generic version,known as fluticasone propionatenasal spray, is being manufactured byRoxane Laboratories.