Posted by Crazy Horse on January 25, 2007, at 19:55:45
In reply to Wyeth gets approvable letter from FDA for Pristiq, posted by ed_uk on January 25, 2007, at 14:23:39
> Wyeth Pharmaceuticals has announced that they have received an approvable letter from the U.S. Food and Drug Administration (US FDA) for desvenlafaxine succinate (Pristiq) for the treatment of adults with major depressive disorder (MDD).
>
> However, the final approval will be based on the following conditions being fulfilled:
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> • A satisfactory FDA inspection of the Company's Puerto Rico facility, which is where Pristiq will be manufactured
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> • Several post-marketing commitments, including submission of long-term relapse prevention, low dose and paediatric studies
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> • Additional clarity around the Company's product education plan for physicians and patients
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> .................................................................................................................
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> Desvenlafaxine (Pristiq) is the active metabolite of venlafaxine (Effexor). I have not read anything which indicates that desvenlafaxine will offer any advantages over venlafaxine whatsoever. In short, Pristiq is a patent-extender. Its introduction will not be of benefit to patients. The directors at Wyeth will be the only people to benefit. It is very disappointing that major pharmaceutical companies are putting so much money into bringing out 'new' drugs which are completely lacking in innovation. Such drugs are not really new drugs at all.......offering no advantages over existing products, they certainly don't bring any hope to the treatment-resistant.
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> In the process of trying to find effective ways to market their 'new' drug, Wyeth is hoping that Pristiq will also be approved for the relief of menopausal vasomotor symptoms.
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> Wyeth claims......
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> 'Women over age 40 represent about 50 percent of the depression market and could benefit from an antidepressant that addresses their symptoms and physiology'
>
> Ed
>Thanks Ed..dissapointing but good to know.
-Monte
poster:Crazy Horse
thread:726403
URL: http://www.dr-bob.org/babble/20070125/msgs/726500.html