Watson announced that the FDA has approved a low dose oral contraceptive, which combines a 24-day active hormone regimen (0.8mg norethindrone and 25mcg ethinyl estradiol) with four tablets containing 75mg of ferrous fumarate, in chewable form. This approval was based on data from a 12-month, multicenter, open-label Phase 3 study conducted on 1,251 women between the ages of 18 and 35 who completed 12,297 treatment cycles. The pregnancy rate (Pearl Index) found in these women was 2.01 pregnancies per 100 women-years of treatment. Women in this study also reported short (mean duration of 3.7 days), predictable periods, with withdrawal bleeding beginning approximately on Day 27 or 28.
No formal trade name has been given to the product at this time.
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