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Yaz "approvable" again

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Schering AG subsidiary Berlex continues to expect a first-quarter 2006 decision on the low-dose oral contraceptive Yaz (ethinyl estradiol 20 mcg/drospirenone 3 mg) following receipt of a second "approvable" letter Jan. 23. The NDA for the low-dose formulation of the firm's successful Yasmin product "is approvable pending [FDA's] review of recently submitted data and their satisfactory conclusion of its content," Berlex says. The approvable decision pertains primarily to additional data regarding patients with premenstrual dysphoric disorder. FDA extended Yaz' PDUFA date in December following submission of additional data (1Pharmaceutical Approvals Monthly December 2005, In Brief)...

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