Yaz
Generic name: drospirenone and ethinyl estradiol
Treatment for: Acne, Birth Control, 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
Related articles
- 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 Extends Review Period of New Drug Application for Oral Contraceptive Yaz to First Quarter 2006 - December 9, 2005
- Berlex Receives Approvable Letter From FDA on the Company's Second Oral Contraceptive Containing Drospirenone - November 18, 2004
Yaz (drospirenone and ethinyl estradiol) FDA Approval History
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