Barr gets US FDA okay for clonazepam tabs
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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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