Home > Archive > Politics and Medicine > May 2006 > New Alcoholism, ADHD Treatments Win Approval From FDA





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Author New Alcoholism, ADHD Treatments Win Approval From FDA
Jan Drew

2006-05-06, 6:29 pm

[ It would be interesting to know just who at the FDA has vested interested
in these two
new approved drugs?]

http://pn.psychiatryonline.org/cgi/content/short/41/9/2

Government News
Excerpts:
Two medications approved by the FDA last month provide significant new
options for treating patients with two common psychiatric disorders.
The U.S. Food and Drug Administration (FDA) granted final marketing approval
to two new products indicated for use in psychiatric disorders. Both
represent treatment options that significantly differ from medications
already on the market.

The FDA granted final approval April 6 to a joint application submitted by
Shire PLC and Noven Pharmaceuticals to market the companies' methylphenidate
transdermal system (MTS) under the brand name Daytrana.

The new patch to treat attention-deficit/hyperactivity disorder (ADHD) is
indicated for use in children aged 6 to 12. Noven will manufacture the
product, while Shire will be responsible for marketing and distributing it
worldwide.

Side-Effect Warning Issued

Its label will include existing warnings regarding sudden death in patients
taking CNS stimulants who have known or occult structural cardiac
abnormalities.


Stuart

2006-05-07, 11:28 am

stuart hyderman stuart hyderman stuart hyderman stuart hyderman


stuart hyderman
stuart hyderman
stuart hyderman
stuart hyderman
stuart hyderman

Jan Drew <jdrew1374@sbcglobal.net> wrote in message
news:%t87g.73529$H71.33220@newssvr13.news.prodigy.com...
> [ It would be interesting to know just who at the FDA has vested

interested
> in these two
> new approved drugs?]
>
> http://pn.psychiatryonline.org/cgi/content/short/41/9/2
>
> Government News
> Excerpts:
> Two medications approved by the FDA last month provide significant new
> options for treating patients with two common psychiatric disorders.
> The U.S. Food and Drug Administration (FDA) granted final marketing

approval
> to two new products indicated for use in psychiatric disorders. Both
> represent treatment options that significantly differ from medications
> already on the market.
>
> The FDA granted final approval April 6 to a joint application submitted by
> Shire PLC and Noven Pharmaceuticals to market the companies'

methylphenidate
> transdermal system (MTS) under the brand name Daytrana.
>
> The new patch to treat attention-deficit/hyperactivity disorder (ADHD) is
> indicated for use in children aged 6 to 12. Noven will manufacture the
> product, while Shire will be responsible for marketing and distributing it
> worldwide.
>
> Side-Effect Warning Issued
>
> Its label will include existing warnings regarding sudden death in

patients
> taking CNS stimulants who have known or occult structural cardiac
> abnormalities.
>
>



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