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ePT--the Electronic Newsletter of Pharmaceutical Technology
GSK Loses Bid to Block Generic "Flonase"
GlaxoSmithKline PLC (GSK, London, England, www.gsk.com) reports that a US Federal District Court judge will not grant a preliminary injunction that would have set aside the US Food and Drug Administration’s (Rockville, MD, www.fda.gov) approval of a generic version of GSK’s “Flonase” (fluticasone)
GSK had challenged FDA’s approval in a lawsuit filed Feb. 23, 2006. The company obtained emergency relief from the court that same day in the form of a 10-day temporary restraining order. The order suspended Roxanne Laboratories Inc.’s (Columbus, OH, www.roxane.com) generic product.
Roxanne had received FDA approval for its fluticasone propionate nasal spray, 50 mcg. With the ruling, Roxanne has resumed shipments of the product, said the company in a release. Roxanne is a subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT, www.boehringer-ingelheim.com).
The ruling also cleared the way for the launch of a GSK-authorized generic marketed by Par Pharmaceuticals Companies Inc. (Spring Valley, NY, www.parpharm.com).
GSK says it will not appeal the ruling. “Flonase,” an intranasal corticosteroid spray used to reduce inflammation associated with rhinitis, posted 2005 sales of £656 million ($1.2 billion).