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US FDA issues “approvable” letter for tipataflam

Posted by ed_uk on November 1, 2006, at 14:16:01

US FDA issues “approvable” letter for tipataflam (Zenvia) for involuntary emotional expression disorder

According to a report by BioSpace, Avanir Pharmaceuticals has announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for tipataflam (Zenvia®) for the treatment of involuntary emotional expression disorder (IEED) in patients with neurological diseases and brain injuries.

According to the report, the FDA has issued an approvable letter, but has requested additional safety and efficacy data.


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poster:ed_uk thread:699609
URL: http://www.dr-bob.org/babble/20061028/msgs/699609.html