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Zoloft Receives FDA Approval For Treatment Of Premenstrual Dysphoric Mood Disorder

NEW YORK, NY — May 21, 2002 —

Pfizer Inc announced that it has received U.S. Food and Drug Administration (FDA) approval for Zoloft® (sertraline HCl) for the treatment of premenstrual dysphoric disorder (PMDD).

 Studies supporting the new indication show that Zoloft is significantly more effective than placebo in treating women who suffer from this condition. PMDD is characterized by intense emotional and physical symptoms that occur during the time between ovulation and menstruation.

 Zoloft is the first and only approved PMDD treatment that is effective if taken either every day or for the two weeks before a woman’s period. “The approval of Zoloft for PMDD means that there is an important new, flexible treatment for women. Effectively treating PMDD can help women regain their ability to function on the days that had previously been lost to PMDD symptoms,” said Cathryn Clary, MD, Worldwide Medical Team Leader, Depression and Anxiety, Pfizer Inc.

 In two randomized, double-blind, placebo-controlled clinical trials involving a total of 532 women diagnosed with PMDD, Zoloft was significantly more effective than placebo in improving PMDD symptoms, including emotional symptoms (e.g., feelings of being depressed, hopeless, overwhelmed) and behavioral symptoms (e.g., angry or irritable, conflicts with people).

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