FDA REBUFFS CONCERNS FOR GENERIC FLONASE

APRIL 01, 2006

In approving the first generic version of GlaxoSmithKline's allergy drug Flonase, FDA officials rejected bioequivalence concerns raised in several citizen petitions that questioned the approval criteria for that drug. After considering the issues raised by those petitioners, FDA officials stressed that generic drug applications are subject to "the same thorough and rigorously scientific review for safety, effectiveness, and quality as the applications for new (branded) drugs."

According to the FDA, "consumers and health professionals can be assured that an approved generic drug is bioequivalent to a brand name drug and is its equal in dosage form, strength, route of administration, quality, performance characteristics, and intended use." The generic version, known as fluticasone propionate nasal spray, is being manufactured by Roxane Laboratories.




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