FDA APPROVES FIRST GENERIC VERSION OF GSK'S FLONASE
The FDA has approved the first generic version of GlaxoSmithKline's (GSK) allergy nasal spray Flonase, the agency announced recently.
The generic version of Flonase (fluticasone propionate) is manufactured by Roxane Laboratories of Columbus, Ohio, the FDA said.
GSK's exclusivity on Flonase expired November 23, 2005, but Roxane's application was not approved until late February 2006. In a teleconference announcing the approval, reporters asked Gary Buehler, director of the FDA's Office of Generic Drugs, to explain the delay. Buehler noted that as of November 2005, the agency had not completed its review of several citizen petitions submitted in response to Roxane's drug application.
The citizen petitions questioned the approval criteria for bioequivalence for Flonase, as well as for other aspects of nasal sprays. GSK submitted three of the petitions, prompting some to allege the company was simply trying to delay generic entry. Buehler said the FDA denied all of the petitions.
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