Posted by Ant-Rock on October 19, 2000, at 18:06:40
In reply to Re: ghb (Xyrem) is still not FDA approved » Ant-Rock, posted by ash on October 19, 2000, at 10:39:34
> Anthony,
>
> A minor correction. I just checked with Orphan Medical. Xyrem(GHB) has NOT yet been approved by the FDA. All Orphan Medical has done is submit an application to the FDA for approval, which contains the results of clininical trials. Actual approval is at least 6 months away, probably closer to a year.
>
> Ash
Sorry Ash, I may have jumped the gun a little. Here's the latest:Xyrem(R)Sodium Oxybate) Oral Solution NDA Receives Priority Review from the FDA
MINNEAPOLIS, Oct. 17 /PRNewswire/ -- Orphan Medical, Inc. (Nasdaq: ORPH) announced today that the Food and Drug Administration (FDA) has granted the Company's Xyrem(R) (sodium oxybate) oral solution New Drug Application (NDA) priority review status. This status obligates FDA to a goal of acting on the NDA within six-months from the date of submission. The FDA grants priority review status for new drugs that represent a significant advancement over available therapies. The NDA for Xyrem was submitted on October 2, 2000, to the FDA, which has sixty days from the date of submission to accept or reject it for review.
poster:Ant-Rock
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URL: http://www.dr-bob.org/babble/20001012/msgs/46797.html