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[note 5] The Washington lawsuit had been raised due to changes in the REMS for mifepristone in January 2023, restricting the previously open access of the drug. The states argued that not only was the January 2023 REMS change too restrictive, but other parts of the current REMS were unnecessary and should be lifted. [57] [58] [59]
As the first week of 2023 rolled on, the U.S. Food and Drug Administration (FDA) quietly released new rules for the dispersal of the abortion medication mifepristone. The decision has the ...
The pharmacy certification process for mifepristone ensures that pharmacies are knowledgeable about and compliant with the REMS (Risk Evaluation and Mitigation Strategies) program.
Mifepristone was developed in 1980 and came into use in France in 1987. [16] It became available in the United States in 2000, for medication abortion, and in 2010, for Cushing's syndrome. [17] [10] [12] It is on the World Health Organization's List of Essential Medicines. [18] Mifepristone was approved in Canada in January 2017. [19] [20]
In 2000, GenBioPro's generic version of mifepristone was approved for medication abortion, as part of a two-drug regimen in combination with misoprostol. In 2023, GenBioPro sued the FDA to obtain a legal judgement confirming that mifepristone could continue to be sold, in spite of anti-abortion laws passed in some states.
The idea of directing the FDA to revoke access to mifepristone is a core policy plan in Project 2025, a 900-plus page document written by conservative groups and organized by the Heritage ...
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.
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