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clonazepam ODT: new generic approved

Posted by Iansf on August 24, 2005, at 12:41:28

On Aug. 3, the FDA approved first-time generic formulations of clonazepam 0.125-, 0.25-, 0.5-, 1-, and 2-mg orally disintegrating tablets ([ODT] made by Kali Laboratories, Inc.; brand name, Klonopin rapidly disintegrating tablets; made by Roche).

Generic formulations of clonazepam ODT made by Barr Pharmaceuticals, Inc., were approved on Aug. 10.

Clonazepam ODT is indicated for use alone or as an adjunct in the treatment of seizure disorders including akinetic and myoclonic seizures, and Lennox-Gastaut syndrome (petit mal variant). It is also indicated as monotherapy for panic disorder with or without agoraphobia, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.


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