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Barr Seasonale approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Barr's Seasonale (levonorgestrel/ethinyl estradiol) becomes the first extended-cycle oral contraceptive with Sept. 5 approval from FDA. Barr expects to make the product, available as 0.15 mg/0.03 mg tablets, available by the end of October. Unlike a conventional 28-day contraception regimen, Seasonale is taken for 91 days (84 days active). Labeling includes a warning that the extended regimen's "convenience of fewer planned menses (four per year instead of 13 per year) should be weighed against the inconvenience of increased intermenstrual bleeding and/or spotting"; 7.7% of Seasonale patients withdrew from a pivotal trial due to unacceptable bleeding vs. 1.8% of patients on the conventional regimen. The warnings section also notes greater annual hormonal exposure compared to the 28-day regimen...
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