Schering: FDA won't require further studies on YAZ for premenstrual disorder

By E. Janene Geiss

Philadelphia, Jan. 25 - Schering AG said Wednesday that its U.S. affiliate, Berlex Inc., has received an approvable letter from the Food and Drug Administration indicating that the premenstrual dysphoric disorder application for YAZ is approvable pending its review of recently submitted data and satisfactory conclusion of its content.

The FDA has not requested additional clinical studies, according to a company news release.

Schering said it anticipates a decision on YAZ in the first quarter of 2006.

Schering is a Berlin, Germany, research-based pharmaceutical company focused gynecology and andrology, oncology, diagnostic imaging and specialized therapeutics for disabling diseases.

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