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GlaxoSmithKline loses fluticasone case

March 25, 2006

US District Court for the District of Maryland has declined to grant a preliminary injunction that would have set aside the FDA's approval of Apotex' generic version of Flonase (fluticasone propionate nasal spray) whilst GlaxoSmithKline pursued its legal challenge of the approval, GlaxoSmithKline release said.

GlaxoSmithKline had challenged the FDA's approval of Apotex in a lawsuit filed on 23rd February 2006. At the time, the company had been able to gain emergency relief from the Court on the same day in the form of a ten-day temporary restraining order, which suspended the FDA's approval of Roxane's generic.

However, the new Court move has cleared the way for Roxane to be able to launch its version immediately. GlaxoSmithKline commented that it would not appeal the ruling.

Following this, Roxane Laboratories announced that it was resuming the shipments of its fluticasone product immediately. The company noted that the Court had found that the FDA's approval process was well within the law, adding that as a result of the ruling, the FDA had lifted its temporary suspension of its approval of Roxane's product.

The move also led to Par Pharmaceutical Companies resuming shipment of its fluticasone product. Par had entered into an authorised generic agreement with GlaxoSmithKline. Under the terms of the agreement, Par would begin shipping fluticasone spray once another generic equivalent of Flonase became available in the US. 

Par's version is manufactured by a subsidiary of GlaxoSmithKline, and GlaxoSmithKline will receive a share of Par's profits.

Flonase is an intranasal corticosteroid spray that helps reduce inflammation and relieves nasal symptoms associated with seasonal and perennial allergic and perennial non-allergic rhinitis. Annual US sales of the drug exceed US$900 million.

GlaxoSmithKline noted that the patent covering the product expired in 2004, taking into account an extension for paediatric exclusivity.

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