FDA Declines To Clear Pfizer Antidepressant For Menopausal Symptoms

From The Wall Street Journal:

Pfizer Inc. (PFE) said the U.S. Food and Drug Administration declined to approve an application to market the antidepressant Pristiq as a treatment for certain menopausal symptoms such as hot flashes.

The New York-based drug maker said in a statement on its website Sept. 8 it had received a "complete response letter" from the FDA, which means the Pristiq application cannot be approved in its current form.

Pfizer said it's evaluating the content of the letter and plans further discussions with the FDA.

Posted: 9/16/2011 12:36:00 PM

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