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Athena Diastat rectal gel user fee deadline is Dec. 4; safety and efficacy found by FDA.

Executive Summary

ATHENA NEUROSCIENCES DIASTAT USER FEE DATE IS DEC. 4 for FDA action on the NDA for diazepam rectal gel in suppository form as an adjunct to standard anti-epileptic therapy for the treatment of acute repetitive seizures. Athena submitted NDA 20-648 for Diastat on Dec. 4, 1995; the application is receiving a standard 12-month review at FDA.
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PS029166

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