🚀 go-pugleaf

What relevance does your sweeping generalisation have to discourse in this NG?
Find a more appropriate venue for your political/economic opinions!

In article <36d3569c.8475393@news.twics.com>,
  patanie@pasdepubyahoo.com (Claude de Contrecoeur) wrote:
> Look at the duplicity of the american FDA. They have labelled Gamma-OH
> a "dangerous" drug and,now,look what they do...
> This is typical of US commercial maneuvers to attack foreign
> products:demonisation,until they can catch up.
>
> Claude
>
> Source: Press Release from Orphan Medical, Inc.
>
> PR Contact: John Howell Bullion, Orphan Medical, Inc. , (612) 513-6900
>
> Orphan Medical Announces FDA Approval to Initiate
>                        A Treatment IND Program
>          for Xyrem (Sodium Oxybate) Oral Solution
>
> MINNEAPOLIS, Minnesota � December 17, 1998 � Orphan Medical, Inc.
> (Nasdaq:
> ORPH) announced today the approval by the Food and Drug Administration
> (FDA) of a Treatment IND (Investigational New Drug) for Xyrem (sodium
> oxybate.Gamma-OH,in French) oral solution. Xyrem is intended to treat
> narcolepsy, including
> the reduction of cataplexy. Narcolepsy is a chronic neurologic
> disorder
> characterized primarily by unavoidable daytime sleep episodes and
> cataplexy. Cataplexy, a sudden and often total loss of muscle control,
> affects the majority of narcolepsy patients. Narcolepsy is estimated
> to
> affect at least 125,000 patients in the United States.
>
> During the Treatment IND, expected to begin in the first quarter of
> 1999,
> the Company will collect additional clinical data necessary for the
> submission of a new drug application (NDA) to the FDA. The FDA permits
> an
> investigational drug to be used under a Treatment IND ---->if there is
> sufficient evidence of safety and effectiveness and the drug is
> intended to
> treat a serious disease.<---- no comment.
>
> ``This is a very important milestone for Orphan Medical,'' said John
> Bullion, CEO of Orphan Medical. ``The initiation of a Treatment IND
> will
> enable the company to seek reimbursement for certain development costs
> while we gather additional clinical data.''
>
> Orphan Medical, Inc. is dedicated to patients with inadequately
> treated or
> uncommon diseases. To this end, the Company acquires, develops, and
> markets
> products of high medical value that address these diseases within
> selected
> strategic therapeutic market segments.
>
> Orphan Medical's Internet Web Site address is http://www.orphan.com
>

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