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Re: Reboxetrine

Posted by Terry on March 15, 1999, at 10:49:26

In reply to Re: Reboxetrine, posted by Annie on March 15, 1999, at 8:57:54

Mr. Steve -- There is no way to know definitively when a drug will be approved. Pharmacia & Upjohn and the FDA will not tell you when a drug will be approved once a new drug application has been submitted to the FDA. However, generally, unless there are major problems, drugs are approved within one to two years of an NDA application. In 1997, P&J said they expected the drug to be approved this year (1999), so it's possible it may be approved soon. Terry

> Psychiatric Times July 1998 Vol. XV Issue 7
> --------------------------------------------------------------------------------
> A New Drug Application was submitted to the U.S. Food and Drug Administration in May for the selective norepinephrine reuptake inhibitor (SNRI) antidepressant, reboxetine. The manufacturer, Pharmacia & Upjohn, has marketed the antidepressant as Edronax in the United Kingdom since July 1997, and in October 1997 received approval through the European Mutual Recognition Procedure to distribute it in 11 other European Union Countries during 1998.
> > Does anyone know when this med will be available in the U.S.?




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