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Women's Health Weekly

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Contraception



NDA filed with U.S. FDA for oral contraceptive with uninterrupted dosing regimen



August 25th, 2005

Wyeth Pharmaceuticals, a division of Wyeth (WYE), announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's new drug application (NDA) for a new combination oral contraceptive containing levonorgestrel/ethinyl estradiol with a first-of-its-kind dosing regimen.

The product is designed to be taken every day, without a placebo phase and eliminates the menstrual cycle, and may offer some women, over time, the potential to eliminate the associated bleeding.

Wyeth is seeking market approval for the product for the prevention of pregnancy in women who elect to use oral contraception and who have no known...


Source: Women's Health Weekly (2005-08-25)

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