FDA Approves Extended-Cycle Oral Contraceptive Seasonique

The US FDA has approved Duramed Pharmaceuticals, Inc's New Drug Application (NDA) for Seasonique, a novel extended-cycle oral contraceptive. Seasonique is similar to the Seasonale, launched by the company in 2003, but differs in that instead of bearing 7 placebo pills, continuous hormonal support is provided in the form of low-dose estrogen ( 0.01 mg ethinyl estradiol). The regimen is also designed to reduce women's menstrual bleeding periods to four, instead of the usual 13.

Barr Pharmaceuticals, Inc, of which Duramed is a subsidiary, said that product labels have already been approved and Seasonique is expected to be available per prescription to end users by July 2006.

More details from Barr Pharmaceuticals' press release.