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Yaz FDA Approval History

FDA Approved: Yes (First approved March 16, 2006)
Brand name: Yaz
Generic name: drospirenone and ethinyl estradiol
Dosage form: Tablets
Company: Berlex, Inc.
Treatment for: Acne, Birth Control, Premenstrual Dysphoric Disorder

Yaz (drospirenone and ethinyl estradiol) is a combination oral contraceptive indicated for prevention of pregnancy in women who elect to use an oral contraceptive, treatment of symptoms of premenstrual dysphoric disorder and for the treatment of moderate acne vulgaris.

Development timeline for Yaz

Jan 30, 2007Approval FDA Approves New Indication for Yaz to Treat Acne
Oct  4, 2006Approval Yaz Acne - Treatment for Prevention of Pregnancy, Premenstrual Dysphoric Disorder
Mar 17, 2006Approval Yaz Berlex, Inc. - Treatment for Prevention of Pregnancy
Jan 25, 2006FDA Clarifies Status of Yaz PMDD Application
Dec  9, 2005FDA Extends Review Period of New Drug Application for Oral Contraceptive Yaz to First Quarter 2006
Nov 18, 2004Berlex Receives Approvable Letter From FDA on the Company's Second Oral Contraceptive Containing Drospirenone

Further information

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