The USFDA recently approved Duramed Pharmaceuticals, Inc. and Barr Pharmaceuticals, Inc.’s New Drug Application (NDA) for SEASONIQUE™ (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive for the prevention of pregnancy.
In July 2006, SEASONIQUE™ will be shipped to trade consumers and will be available by prescription to women which represents the next generation of extended-cycle oral contraceptives in a category the Company created with the launch of the SEASONALE® extended-cycle oral contraceptive in 2003.
"SEASONIQUE joins SEASONALE in offering American women a new option inextended-cycle oral contraception," said Bruce L. Downey, Chairman and CEO of Barr Pharmaceuticals, Inc. "The science involving extended-cycle oral contraceptives continues to evolve and SEASONIQUE represents an exciting and unique development in this category. SEASONIQUE provides continuous hormonal support in the form of a low-dose of estrogen in place of the seven placebo pills. There is no other product like SEASONIQUE on the market today."Source: Barr Labs Press Release
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