FDA approves Watson's novel oral contraceptive

Dec 22 2010

Watson Pharmaceuticals (NYSE: WPI) today announced the U.S. Food and Drug Administration (FDA) approval of a novel oral contraceptive product – the first and only low dose oral contraceptive to combine 0.8 mg norethindrone and 0.025 mg ethinyl estradiol in chewable form, with four 75 mg ferrous fumarate (iron) placebo tablets. Taken orally, once daily, the product is proven effective in lowering the risk of pregnancy.

Watson's new oral contraceptive is a novel alternative to currently available birth control pills.  This pill's unique dosing combination and proven 24-day, active hormone regimen is intended to provide users with a low level of breakthrough bleeding and short, light, predictable periods.

"The approval of this oral contraceptive further strengthens Watson's robust and expanding branded Women's Health portfolio," said Fred Wilkinson, Executive Vice President, Global Brands. "We believe this product is an important addition to the oral contraceptive category, and that its characteristics will make it a desirable choice for women."

The novel contraceptive product, licensed from a subsidiary of Warner Chilcott plc, will be actively marketed to physicians by Watson's Global Brands division beginning in the second quarter 2011.

Recent partnerships with Gedeon Richter, HRA Pharma, Itero Biopharmaceuticals, the Population Council and Columbia Laboratories have enabled Watson to expand its branded offerings and pipeline in women's health to include therapies for infertility, prevention of pre-term birth, uterine fibroids, emergency contraception and long-term contraception.

The approval of the oral contraceptive is based on data from a 12-month, Phase 3, multicenter, open-label study that evaluated the safety and efficacy of the product for pregnancy prevention.  Among 1,251 women between the ages of 18 and 35 who completed 12,297 treatment cycles, the pregnancy rate (Pearl Index) in women was 2.01 pregnancies per 100 women-years of treatment.  In addition, women in the clinical trial reported short (mean duration of 3.7 days), predictable periods, with withdrawal bleeding beginning approximately on Day 27 or 28.