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Re: Xyrem - FDA Approval? NSF correction

Posted by Henry in NY on July 06, 2001 at 12:58:43:

In Reply to: Xyrem - FDA Approval? posted by Carol on July 02, 2001 at 09:30:00:

Got this email correction from the NSF.

CORRECTION

In a news release issued Tuesday afternoon, July 3, the National Sleep Foundation (NSF)misinterpreted a ruling by the Food and Drug Administration regarding Xyrem ®, a new drug for treating a symptom of narcolepsy. Instead of Xyrem ® being "approved" by the FDA, as the NSF release stated, the agency has determined the drug is "approvable," though additional
requirements must be met for approval.
We regret the error and apologize for any confusion it may have caused.


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