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Re: Xyrem - FDA Approval?


Posted by philip on July 02, 2001 at 20:10:56:

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

The advisory panel met on june 6, the fda is supposed to give its final word about one month later so I would be looking for something on the net this week. If approved I think they said ghb would be availeable this fall. You will not be allowed to get it at your regular pharmacy or from a regular doc you have to get it from a doc that has sleep disorders experience and he will fax the Rx to a special pharmacy in minesota if I remember correctly and it will be shipped to you by some specialy trained federal express people and then the pharmacy calls to make sure you got it the next day. I don't think they have decided yet but you may have to have a special locking medical box etc to store it at home. The whole xyrem thing is going to be high security, personaly I wouldn't tell anyone about xyrem or that I had any. At anyrate your doc and the shipping pharmacy will give you the lowdown when the time comes.

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