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Orphan Medical Xyrem new user goal

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

User fee goal date for Orphan Medical's Xyrem is July 17 following the firm's May 17 response to an "approvable" letter. The company's "response includes clarification of respiratory data and revisions to labeling," as requested in the April 9 approvable letter. The firm also notes that FDA conducted an additional clinical trial site review, which resulted in "no issued findings." The Xyrem NDA, submitted in October 2000, seeks approval of the sodium oxybate oral solution as a treatment for cataplexy associated with narcolepsy. FDA's first approvable letter for the product, issued July 2, 2001, requested information on respiratory-compromised patients and safety data from ongoing trial

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