YazTreatment for Acne, Birth Control, Premenstrual Dysphoric Disorder
FDA Extends Review Period of New Drug Application for Oral Contraceptive Yaz to First Quarter 2006
BERLIN, December 9, 2005 -- Schering AG, Germany announced today that the US Food and Drug Administration (FDA) has informed Schering's U.S. affiliate, Berlex, Inc., that it is extending the review period for the new drug application (NDA) regarding its new oral contraceptive Yaz containing 20 micrograms ethinyl estradiol and 3 milligrams drospirenone, in a unique, 24-day regimen.
"We now expect a decision from the FDA in the first quarter of 2006," said Phil Smits, M.D., Head of Gynecology&Andrology at Schering AG. "We are optimistic that Yaz will be available to women in the first half of 2006."
A unique feature of Yaz is an innovative dosing regimen of 24 days of active pills followed by 4 days of placebo pills. In the United States, oral contraceptives typically contain 21 days of active pills with 7 days of placebo.
Source: Schering AG
Posted: December 2005
- FDA Approves New Indication for Yaz to Treat Acne - January 30, 2007
- Yaz Acne - Treatment for Prevention of Pregnancy, Premenstrual Dysphoric Disorder - October 4, 2006
- Yaz Berlex, Inc. - Treatment for Prevention of Pregnancy - March 17, 2006
- FDA Clarifies Status of Yaz PMDD Application - January 25, 2006
- Berlex Receives Approvable Letter From FDA on the Company's Second Oral Contraceptive Containing Drospirenone - November 18, 2004
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