Orphan Medical Xyrem clears FDA
This article was originally published in Pharmaceutical Approvals Monthly
Orphan Medical will launch Xyrem in the fourth quarter, allowing for time to establish the risk management program, train the sales force and build inventory. Xyrem (sodium oxybate) cleared FDA July 17 for the reduction of cataplexy attacks in patients with narcolepsy. The Schedule III drug must be distributed through a central pharmacy, with a physician and patient registry, and patients must be evaluated by the prescriber with every new prescription (every three months). The company plans to file for treatment of excessive daytime sleepiness related to narcolepsy in mid-200
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