FDAnews
www.fdanews.com/articles/75348-barr-receives-approval-for-clonazepam-tablets

BARR RECEIVES APPROVAL FOR CLONAZEPAM TABLETS

August 12, 2005

Barr Laboratories has received final approval from the FDA for its application to manufacture and market Clonazepam Orally Disintegrating Tablets in 0.125-mg, 0.25-mg, 0.5-mg, 1-mg and 2-mg dosage strengths.

Barr's product is the generic equivalent of Hoffman-La Roche's Klonopin Wafers. Clonazepam is intended to treat Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures, and 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 said it intends to launch its product immediately.