Searle Cytotec
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA is negotiating with Searle to change the misoprostol label to reflect the potential for use in the Mifeprex pregnancy-termination regimen, FDA Commissioner Jane Henney, MD, told a House Commerce/Oversight Subcommittee hearing Oct. 3. Pharmacia subsidiary Searle issued a "Dear Health Care Provider" letter in August emphasizing that its gastric ulcer treatment is contraindicated for use in pregnant women and not approved for induction of labor or abortion. Danco Labs expects Mifeprex to be available in late October, and FDA presumably would want to have Cytotec labeling updated for Mifeprex's launc