The US entity of Bayer Schering Pharma AG, Germany, has received the US Food and Drug Administration (FDA) approval for its new Natazia (estradiol valerate/ dienogest) pill for the prevention of pregnancy. This new product with an estradiol valerate/ dienogest combination is the first in a new class of oral contraceptives to deliver estradiol. Natazia is expected to be available in the US this summer. Outside the US the product is marketed as Qlaira since May 2009.
“We are very pleased that now also women in the U.S. have the option to choose our new oral contraceptive Natazia as an effective option for the prevention of pregnancy,” said Phil Smits of Bayer Schering Pharma’s business unit Women’s Healthcare. “We are also working with the US FDA on an indication for menstrual bleeding disorders to offer women a tailored therapy for this debilitating condition,” Smits said.
Natazia delivers varying doses of estradiol valerate, and the combination of estradiol valerate and dienogest on different days of the cycle. One Natazia pill is taken daily for 28 days, including 22 days of estradiol valerate/dienogest, four days of estradiol valerate alone and two hormone free pills.
The US FDA approval of Natazia for the prevention of pregnancy is based on a New Drug Application (NDA) that included efficacy and safety data from a clinical study programme comprising three multi-center trials involving a total of 2,266 healthy women aged 18-50 years.