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U.S. FDA Approves Natazia(TM), a New Oral Contraceptive for the Prevention of Pregnancy
Date:5/6/2010

on with dienogest, for specific days of the 28-day cycle.

"We are very pleased that the FDA has approved Natazia as an effective option for the prevention of pregnancy, as it further demonstrates the commitment of Bayer Women's Healthcare to meeting the individual needs of women," said Stefan Oelrich, Vice President and General Manager, Women's Health Care, Bayer HealthCare Pharmaceuticals.

Natazia should not be used in women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal genital bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors (benign or malignant) or liver disease, or who are pregnant.

The use of Natazia is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, hypertension, ruptured ovarian cyst and uterine leiomyoma.  The excess risk of thromboembolic events is highest during the first year of use of COC.

Patients should be counseled that OCs do not protect against HIV infection and other sexually transmitted diseases.

About Natazia's Clinical Trials

Overall Efficacy and Safety

The safety and efficacy of Natazia as an oral contraceptive was evaluated in two multicenter phase 3 clinical trials in North America and Europe involving 1,867 women.  Natazia was found to be effective as a hormonal contraceptive in both studies.

The Pearl Index (PI) was the primary measure for assessing contraceptive reliability for two of the studies and found Natazia to be hi
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
Copyright©2010 PR Newswire.
All rights reserved

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