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Berlex’ Yaz “approvable”

Executive Summary

Berlex' oral contraceptive Yaz (ethinyl estradiol 20 mcg/drospirenone 3 mg) is "approvable" at FDA, company says Nov. 18. Schering AG subsidiary says FDA seeks additional data to support the pill's "unique dosing regimen" of 24 days of active pills, in contrast to the standard 21-day regimen. Berlex plans to submit data "to support the clinical benefit of the additional three days of active pills in each cycle" by the end of 2004. Yaz is the low-dose version of Yasmin; FDA had extended is review timeline for the product (1"The Pink Sheet" July 26, 2004, In Brief)...
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