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Executive Summary

Second "approvable" letter for abortifacient (RU-486) sent to the Population Council Feb. 18. The drug was first deemed "approvable" on Sept. 18, 1996, pending resolution of manufacturing issues. The Population Council's licensee for mifepristone, Danco Laboratories, said it "is currently preparing information to satisfy the FDA's request." A timely response by Danco would allow FDA to clear the drug ahead of the Presidential nominating conventions this summer

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