The Population Council filed an application last month seeking to market RU-486, the Food and Drug Administration announced Monday (4-1). The review could take up to a year, the amount of time the FDA usually spends on drugs that do not affect life-threatening diseases. Last year the FDA estimated that approval could take as little as six months because of the RU-486’s extensive record of safety and efficacy.
The Population Council, which was awarded RU-486 patent rights from Rossel Uclaf in May 1994, has given exclusive legal rights for coordinating the drug’s manufacture and distribution to a new company called Advances in Health Technology.
The Feminist Majority Foundation has been leading the fight to bring RU-486 to the U.S. since 1989. See the Campaign for RU-486 and Contraceptive Research.