Bayer HealthCare Natazia Contraceptive Tablets Get FDA Nod

Bayer HealthCare Pharmaceuticals claimed that 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.

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.

Bayer HealthCare Pharmaceuticals said that 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.

Stefan Oelrich, vice president and general manager of women’s health care at Bayer HealthCare Pharmaceuticals, said: “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.”