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PHARMA - LENNOX-GASTATUT SYNDROME

Barr gets US FDA okay for clonazepam tabs

 

BY OUR PHARMA CORRESPONDENT

13th August,2005:Barr Pharmaceuticals, Inc. announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its application to manufacture and market clonazepam orally disintegrating tablets, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg & 2 mg.

Barr's clonazepam tablet is the generic equivalent of Hoffman La Roche's Klonopin Wafers. The Company plans to launch its product immediately.

Klonopin (clonazepam) is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures, and, for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV.

Klonopin Wafers had total annual sales of approximately $18 million, based on IMS sales data for the twelve months ended June 2005.

Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.

BY OUR PHARMA CORRESPONDENT
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