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September 28, 2000

The federal Food and Drug Administration's decision to allow marketing of mifepristone gives American women an important alternative for early abortion.

On September 28, 2000, the US Food and Drug Administration granted approval for use of mifepristone for termination of early pregnancy. The decision was based on more than a decade of experience with the drug in other countries, as well as clinical trials involving nearly 2,000 women in the United States.

The application for mifepristone's approval was submitted by the New York-based Population Council, and the drug will be marketed by Danco Laboratories of New York under the brand name Mifeprex. It is expected to become available to U.S. physicians by late November.

The FDA's terms

Under the terms of the Food and Drug Administration's approval, mifepristone can be used to terminate pregnancy from the time a woman discovers that she is pregnant until seven weeks after the first day of her last menstrual period. The regimen approved for the United States is three 200 mg doses of mifepristone taken orally, followed 48 hours later by a 400-µg dose of the prostaglandin misoprostol, also administered orally. Women who choose the method will be required to make three visits to a doctor's office over a two-week period: one for a physical examination and to take the mifepristone, one to take the misoprostol, and one to confirm that complete abortion has occurred.

Research and experience in other countries confirm that a dosage of only 200 mg of mifepristone is equally effective in inducing early abortion, that the method can be used successfully and safely at least several weeks later in pregnancy, and that the number of required doctor's visits can be safely reduced.

Where to obtain mifepristone

Information about clinics or doctor's offices where mifepristone/misoprostol abortion will be available can be obtained from the Planned Parenthood Federation of America, the National Abortion Federation, Abortion Clinics Online and the National Coalition of Abortion Providers .

For more information, contact:
Kirsten Sherk
Senior Associate, Media Relations
e-mail: sherkk@ipas.org
phone: 919.960.5612
fax: 919.929.0258