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Roche Klonopin approved for panic disorder April 9; titrating doses also cleared.

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Executive Summary

ROCHE KLONOPIN APPROVED FOR PANIC DISORDER APRIL 9 along with FDA approval of two new strength tablets, .125 mg and .25 mg, making it the second benzodiazepine for the indication. NDA 17-533/S-023 was deemed "approvable" by FDA Nov. 7, 1996. Pharmacia & Upjohn's benzodiazepine Xanax (alprazolam) carries a panic indication, as does SmithKline Beecham's selective serotonin reuptake inhibitor Paxil (paroxetine). Klonopin is marketed as an anticonvulsant.

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