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Seasonique FDA Approval History

FDA Approved: Yes (First approved May 25, 2006)
Brand name: Seasonique
Generic name: levonorgestrel and ethinyl estradiol
Dosage form: Extended-Cycle Oral Contraceptive Tablets
Company: Duramed Pharmaceuticals, Inc.
Treatment for: Birth Control

Seasonique (levonorgestrel/ethinyl estradiol) is an extended-cycle oral contraceptive regimen designed to reduce the number of withdrawal bleeding periods from monthly to four per year. Seasonique is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of birth control.

Development timeline for Seasonique

May 27, 2006Approval FDA Approves Duramed's Seasonique Extended-Cycle Oral Contraceptive
Mar 17, 2006Barr Confirms that Additional Clinical Data Is Not Required for Approval of Duramed's Seasonique Extended-Cycle Oral Contraceptive
Aug 18, 2005Barr Receives Approvable Letter for Duramed's Seasonique Extended-Cycle Oral Contraceptive
Dec 22, 2004Duramed's Seasonique NDA Accepted for Filing by FDA

Further information

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