Natazia tablets receive FDA approval for prevention of pregnancy

Bayer HealthCare Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Natazia™ (estradiol valerate and estradiol valerate/dienogest) tablets for the prevention of pregnancy.  Natazia has not been evaluated in women with a BMI of greater than 30 kg/m(2).  Natazia is the first and only oral contraceptive that contains an estrogen called estradiol valerate and a progestin called dienogest.  Estradiol valerate is a synthetic estrogen that is converted to estradiol in a woman's body.  Natazia is expected to be available in the summer.

Until today, all marketed combination oral contraceptives (COCs) contained ethinyl estradiol.  With the FDA approval of Natazia, Bayer HealthCare Pharmaceuticals becomes the first company to launch estradiol valerate together with the progestin, dienogest.

"Every woman's body reacts differently to hormones, so it is important that they have a choice in birth control options," said Anita Nelson, MD, professor of obstetrics and gynecology at the Harbor-UCLA Medical Center, Torrance, California.  "Natazia may be a good option for women to consider when making a decision with their healthcare provider about which birth control option is right for them."

Women using COCs, including Natazia, should be strongly advised not to smoke.  Smoking increases the risk of serious cardiovascular side effects from COC use.  The risk increases with age and the number of cigarettes, especially in women over 35 years old.

Natazia is taken once a day.  The dosing regimen consists of pills with varying doses of estradiol valerate, and estradiol valerate in combination 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.

Source:

Bayer HealthCare Pharmaceuticals Inc.

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