Bayer Schering Pharma has submitted a New Drug Application (NDA) to the FDA for a new estradiol-based oral contraceptive (estradiol valerate/dienogest). It seeks approval for the indications oral contraception and treatment of heavy and/or prolonged menstrual bleeding.
The company claims that the new oral contraceptive contains the combination of estradiol valerate (which is immediately metabolized to estradiol) equivalent to the estrogen as produced by a woman’s ovaries with the progestin dienogest.
Phil Smits, Head of Women’s Healthcare, Bayer Schering Pharma, said: “We are pleased to be able to submit the NDA for this new estradiol-based oral contraceptive in the US only a few weeks after Qlaira’s launch in Europe. We see a high interest in this new oral contraceptive by women and gynecologists. The NDA underscores the culmination of years of research and development that confirms our goal of developing innovative products that deliver benefits beyond reliable contraception.