YazTreatment for Acne, Contraception, Premenstrual Dysphoric Disorder
FDA Clarifies Status of Yaz PMDD Application
BERLIN, Germany, January 25, 2006 -- Schering AG, Germany announced today that its U.S. affiliate, Berlex, Inc., has received an approvable letter from the U.S. Food and Drug Administration (FDA) indicating that the premenstrual dysphoric disorder (PMDD) application for Yaz is approvable pending their review of recently submitted data and their satisfactory conclusion on its content. The FDA has not requested additional clinical studies.
Schering anticipates a decision on Yaz in the first quarter of 2006.
Source: Schering AG
Posted: January 2006
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