(Reuters) -The U.S. Food and Drug Administration has approved Evita Solution’s generic version of the abortion drug, mifepristone, the regulator said.
The FDA said in a letter dated September 30 it has approved Evita’s generic version of Danco Laboratories’ mifepristone, which is used to terminate pregnancy at up to 10 weeks.
The drug is manufactured by the privately held company that describes its mission as being to “normalize abortion” and make it “accessible to all.”
GenBioPro, another private company, also sells a generic version of Danco Labs’ mifepristone.
The approval comes amid heightened scrutiny of abortion drugs, with the FDA currently reviewing the safety of mifepristone following pressure from conservative lawmakers and state attorneys general.
U.S. Health Secretary Robert F. Kennedy Jr. said in a post on X that “the Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap.”
“U.S. FDA only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug,” he added.
The FDA has said that after decades of use by millions of women in the United States and around the world, mifepristone has proven “extremely safe,” and that studies have demonstrated that “serious adverse events are exceedingly rare.”
The FDA first approved mifepristone in combination with misoprostol in 2000.
Mifepristone blocks progesterone, the hormone that helps a woman’s body maintain the lining of the uterus during pregnancy. Misoprostol is then taken to complete the abortion process.
In August, Costco Wholesale said it would not sell mifepristone across its U.S. pharmacy stores, citing low demand.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Alan Barona)
