GSK Statement Regarding Flonase(R) Generic

Main Category: Litigation / Medical Malpractice
Also Included In: Pharma Industry / Biotech Industry;  Allergy;  Ear, Nose and Throat
Article Date: 11 Mar 2006 - 1:00 PDT

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GlaxoSmithKline (GSK) announced today that a federal court judge has declined to grant a preliminary injunction that would set aside the U.S. Food and Drug Administration's approval of a generic version of Flonase(R) - while GSK pursues its legal challenge of the approval.

U.S. District Court Judge Andre Davis made the ruling Monday, following a hearing in Baltimore. GSK will not appeal the ruling.

GSK had challenged the 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 FDA's approval of Roxane Laboratories' generic product.

The March 6 ruling cleared the way for immediate launch of the generic product manufactured by Roxane Laboratories as well as a GSK-authorized generic marketed by Par Pharmaceuticals.

The patent covering Flonase (R) expired in 2004, taking into account an extension for pediatric exclusivity. Flonase (R) is an intranasal corticosteroid spray that helps reduce inflammation and relieves the nasal symptoms associated with seasonal and perennial allergic and perennial non-allergic rhinitis.

GlaxoSmithKline, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

For more information, please visit the company's web site at http://www.gsk.com