Berlex Yaz 90-day extension
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Schering AG subsidiary Berlex expects approval of its low-dose Yasmin formulation Yaz (ethinyl estradiol 20 mcg/drospirenone 3 mg) in the first quarter of 2006, the firm says Dec. 9 after a 90-day extension of the oral contraceptive's PDUFA date. Berlex says that "shortly after" receipt of a November 2004 "approvable" letter, it submitted information on the formulation's dosing regimen (24 days of active pills, 4 days inactive) as well as data to support an additional indication for premenstrual dysphoric disorder...