First developed in France by pharmaceutical maker Roussel Uclaf.
Approved for use in France.
June 9, 1989
FDA, citing safety concerns, places import alert on RU486.
January 22, 1993
On his third day in office, Clinton signs executive order directing HHS and FDA to expedite testing, licensing, and marketing of RU486 in U.S.
May 1, 1994
After months of U.S. government-brokered negotiations, Roussel Uclaf "donates" U.S. patent to Population Council of New York.
October 27, 1994
Population Council announces beginning of U.S. trial of RU486 involving 2,100 women.
Labor Day, 1995
U.S. trial of RU486 ends.
March 18, 1996
Population Council files marketing application with the FDA.
July 19, 1996
Stacked FDA advisory panel declares RU486/PG method "safe," "effective," recommends approval.
September 18, 1996
FDA issues letter declaring RU486 "approvable," yet withholds final approval pending the resolution of certain "manufacturing" and "labeling" issues.
October 31, 1996
Lawsuits by would-be investors expose that the Population Council had selected a man to handle financing for RU486 project who had been convicted of forgery in a fraudulent real estate scheme.
February 12, 1997
Population Council settles suit, removes forger from day-to-day operations on RU486 project.
February 28, 1997
Hungarian manufacturer lined up to produce RU486 backs out of deal. RU486 project delayed indefinitely while search for new manufacturer begins.
April 8, 1997
Roussel Uclaf announces release of remaining RU486 rights to Exelgyn, a new company headed by former Roussel Uclaf chief executive Edouard Sakiz.
April 30, 1998
Results from U.S. clinical trial published in the New England Journal of Medicine.
Stories begin to appear that the Population Council and its for-profit marketing company, Danco Laboratories, have found a manufacturer and expect approval by year's end.
Instead of approval, the FDA issues a second "approvable" letter, indicating it still has unresolved issues with the drug.
Pro-abortion groups complain that the FDA is considering regulations to limit prescription of RU486.
September 28, 2000
FDA announces approval of RU486, drops or modifies many of the safeguards proposed in June.
CLR NOTE (July 2014): In November 2004, the FDA announced that “black box” labeling changes in the packaging of the abortion drug mifepristone (which was then named RU-486) would begin. Danco Laboratories produces mifepristone under its trade name Mifeprex. These revised warnings, the highest level issued by the FDA, indicate the risks such as serious bacterial infections, sepsis, and bleeding and death. As of 2011, the drug is implicated in the deaths of 14 women; 8 of those deaths were associated with sepsis.
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