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Safety data on Orphan Medical's Xyrem (sodium oxybate) in respiratory-compromised patients may be collected post-approval if FDA accepts submission of data on that patient population from an earlier trial, Orphan says. A July 2 "approvable" letter for the narcolepsy treatment indicated that a study would be required before approval. Orphan plans to file the additional data in mid-November and expects a six-month review
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