FDA Holds Back On Final Approval For Mifepristone

22 September 1996

While noting that the abortion pill mifepristone (also known as RU-486) is safe and effective when used under a doctor's close supervision, the US Food and Drug Administration has withheld final approval until it receives more information about how the drug would be made and labeled.

The agency has sent a letter to the Population Council, the nonprofit group that has US rights to the drug from its originator, Roussel Uclaf, requesting further information and the Council has said it will respond quickly.

Once the FDA gets its answers, it has up to six months to review the data. Officials at the agency would not estimate when the drug might reach the doctors' offices, but the PC feels it will be available next year.

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