Low-Dose, Drospirenone-Containing Oral Contraceptive Approved in Europe
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Low-Dose, Drospirenone-Containing Oral Contraceptive Approved in Europe

NEW YORK -- May 7, 2008 -- An oral contraceptive containing the unique progestin drospirenone combined with a low dose of ethinyl estradiol has been approved in the European Union and is expected to be available by autumn 2008. The contraceptive, marketed as Yaz, is available in a new dosing regimen of 24 days of active hormone tablets and 4 days of placebo.

The drospirenone/ethinyl estradiol contraceptive has been available in the United States since 2006, where it is the only oral contraceptive approved for 3 indications: contraception as well as for the treatment of moderate acne and the emotional and physical symptoms associated with premenstrual dysphoric disorder (PMDD), such as mood swings, irritability, anxiety, food cravings, breast tenderness, bloating, and headache.

Bayer Schering Pharma, the makers of the contraceptive, plan to submit for expanded approval in the European Union for both the acne and PMDD indications.

SOURCE: Bayer Schering Pharma

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