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BioPharmaceutical

Orphan Medical Xyrem

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

FDA extends its NDA review goal for the narcolepsy therapy sodium oxybate oral solution by 90 days, to early July, to review recently submitted data requested by the agency. FDA's Peripheral and Central Nervous System Advisory Committee is expected to schedule a June review of the dru
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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