Women's Health Weekly
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Sexual and Reproductive Health
SEASONIQUE NDA accepted for filing by U.S. FDA
January 20th, 2005
Barr Pharmaceuticals, Inc., (BRL) announced that its subsidiary, Duramed Pharmaceuticals, Inc., has received notification that the U.S. Food and Drug Administration (FDA) has accepted for review its 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. The company is seeking approval to manufacture and market SEASONIQUE extended-cycle oral contraceptive for the prevention of pregnancy. "SEASONIQUE represents our second entrant into the extended-cycle oral contraceptive product category we created with the launch of our SEASONALE...
Source: Women's Health Weekly (2005-01-20)
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