Production was intended to begin through the Danco Group in 1996, but they withdrew briefly in 1997 due to a corrupt business partner, delaying availability again.In 2016, the US Food and Drug Administration approved mifepristone, to end a pregnancy through 70 days gestation (70 days or less since the first day of a womans last menstrual period). The approved dosing regimen is 200 mg of mifepristone taken by mouth (swallowed). 24 to 48 hours after taking mifepristone, 800 mcg (micrograms) of misoprostol is taken buccally (in the cheek pouch), at a location appropriate for the patient.Mifepristone tablets have a marketing authorization in the United States for the treatment of high blood sugar caused by high cortisol levels in the blood (hypercortisolism) in adults with endogenous Cushings syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or cannot have surgery.In 2019, the first generic form of mifepristone in the United States became available, manufactured by GenBioPro.Due to the COVID-19 pandemic, safe access to mifepristone was a concern, and the American College of Obstetricians and Gynecologists among other groups filed a lawsuit to relax the FDAs rule as to allow mifepristone to be acquired from mail-order and retail pharmacies.
1997–1999
On 8 April 1997, after buying the remaining 43.5% of Roussel-Uclaf stock in early 1997, Hoechst AG (US$30 (equivalent to $51.83 in 2021) billion annual revenue) announced the end of its manufacture and sale of Mifegyne (US$3.44 (equivalent to $5.94 in 2021) million annual revenue) and the transfer of all rights for medical uses of mifepristone outside of the United States to Exelgyn S.A., a new single-product company immune to antiabortion boycotts, whose CEO was former Roussel-Uclaf CEO Édouard Sakiz. In 1999, Exelgyn won approval of Mifegyne in 11 additional countries, and in 28 more countries over the following decade. Society and culture
Mifepristone is on the World Health Organizations List of Essential Medicines. Since 2019 it has been included on the core list, with misoprostol, with a special note "where permitted under national law and where culturally acceptable". Frequency of use
United States
Medication abortions voluntarily reported by 33 U.S. states to the Centers for Disease Control and Prevention (CDC) have increased as a percentage of total abortions every year since the approval of mifepristone: 1.0% in 2000, 2.9% in 2001, 5.2% in 2002, 7.9% in 2003, 9.3% in 2004, 9.9% in 2005, 10.6% in 2006, and 13.1% in 2007 (20.3% of those at less than 9 weeks gestation).A Guttmacher Institute survey of abortion providers estimated that medication abortions accounted for 17% of all abortions and slightly over 25% of abortions before 9 weeks gestation in the United States in 2008 (94% of nonhospital medication abortions used mifepristone and misoprostol, 6% used methotrexate and misoprostol).