GlaxoSmithKline hit by generic drug approval

The US Food and Drug Administration (FDA) has approved a generic version of GlaxoSmithKline’s (GSK) drug Flonase, marketed in the UK as Flixonase.

Generic fluticasone propionate nasal spray, manufactured by Roxane Laboratories was deemed by regulators to be safe and bioequivilant to the named original version.

“Offering consumers a choice of safe, effective, and reasonably priced generic drug products is an extremely important priority for FDA,” said Steven Galson, director of drug evaluation. “Today’s approval is part of our ongoing commitment to provide generic forms of products to the public.”

But despite GSK’s last Flixonase patent having run out in November, representatives of the company were left fuming by the announcement. Speaking to Reuters, spokesperson Mary Anne Rhyme said that the company was considering a lawsuit against the FDA.

“We’re seriously studying possible next steps… legal action.” She added that GSK will make its decision before the Roxane-manufactured version enters the market.

Flixonase is prescribed to adults and children over four years suffering from nonallergic and allergic rhinitis. It reduces inflammation and stuffiness caused by the condition in the nose, making it easier for the patient to breath.

It had generated sales of over $1 billion for GlaxoSmithKline.

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