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Population Council/Danco Labs Mifeprex

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Companies will conduct a postmarketing safety study for mifepristone to compare outcomes for 710 patients treated by physicians trained in surgical abortion versus those who have not been trained, according to FDA's Sept. 28 approval letter. The abortifacient is indicated for "the medical termination of intrauterine pregnancy through 49 days of pregnancy." Treatment consists of three 200 mg mifepristone tablets followed by two 200 mcg tablets of Searle's gastric ulcer treatment Cytotec (misoprostol) two days late
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