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In September 2000 Danco Laboratories, a sub-licencee of the Population Council, received approval from the US Food and Drug Administration (FDA) to sell mifepristone under the brand name Mifeprex. In 2019, the first generic form of mifepristone in the United States became available, manufactured by GenBioPro. [82]
Danco Laboratories is a pharmaceutical distributor located in midtown Manhattan which distributes the abortifacient drug mifepristone under the brand name Mifeprex. Mifeprex is the only drug distributed by Danco, although the company plans to expand to other drugs in the future.
For medical abortion up to 12 weeks' gestation, the recommended drug dosages are 200 milligrams of mifepristone by mouth, followed one to two days later by 800 micrograms of misoprostol inside the cheek, vaginally, or under the tongue. [18]
Aid Access is a nonprofit organization that provides access to medication abortion by mail to the United States and worldwide. It describes its work as a harm reduction strategy designed to provide safe access to mifepristone and misoprostol for those able to become pregnant in the United States who may not otherwise have access to abortion or miscarriage management services. [2]
Food and Drug Administration v. Alliance for Hippocratic Medicine, 602 U.S. 367 (2024), was a United States Supreme Court case to challenge the U.S. Food and Drug Administration (FDA)'s approval of mifepristone, a drug frequently used in medical abortion procedures.
Mifepristone is approved (under the brand name Mifeprex), in a regimen with misoprostol (a prostaglandin analogue), for ending of a pregnancy up to 70 days post gestation. [43] Mifepristone is additionally approved on its own (under the brand name Korlym) as a treatment for Cushing's syndrome. [44]
Mifepristone (Name Brand: Mifeprex) has been an FDA approved drug since 2000, with the generic product released in 2019, and is the focus of the majority of these challenges. Misoprostol has never been as tightly regulated as mifepristone and is frequently dispensed by retail pharmacies to treat a variety of medical conditions.
Mifepristone (RU-486; Mifegyne, Mifeprex): An antiprogestogen which is widely used as an abortifacient. Also has antiglucocorticoid and AR antagonist activity. Has been found to produce gynecomastia as a side effect in men at a relatively high rate in clinical studies. Has been studied as a treatment for prostate cancer.