Bayer submits oral contraceptive NDA to FDA

Bayer has submitted a new drug application (NDA) to the Food and Drug Administration (FDA) for a new estradiol-based oral contraceptive (estradiol valerate/dienogest).

The company explained that the product is the first in a new line of medications that aim to deliver estradiol to patients.

Estradiol is the type of oestrogen that is produced naturally by the female body and has been linked to the treatment of heavy menstrual bleeding.

Dr Phil Smits, head of women’s healthcare at Bayer Schering Pharma, said that there has been a great deal of interest in the product from women patients and gynaecologists.

“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,” he added.

Last month, Bayer announced that it has entered into an exclusive licence agreement with Celera Corporation, which provides the firm with access to a range of cancer-related targets for therapeutic development.