FDA approves another generic version of abortion pill mifepristone
FILE-In this photo illustration, packages of mifepristone tablets are displayed at a family planning clinic on April 13, 2023 in Rockville, Maryland. (Photo illustration by Anna Moneymaker/Getty Images)
Food and Drug Administration officials have approved another generic version of the abortion pill mifepristone.
The Associated Press reported that drugmaker Evita Solutions shared on its website that the FDA authorized its low-cost form of the pill, which is approved to end pregnancies through 10 weeks.
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An FDA spokesperson told the AP that the agency "has very limited discretion in deciding whether to approve a generic drug," and added that FDA officials do not "endorse any product."
In an email from Evita Solutions obtained by the AP, the company said the drug is expected to roll out in January 2026.
Has the FDA approved mifepristone in the past?
The backstory:
In 2000, the Food and Drug Administration authorized the original version of mifepristone and made it more accessible through the years.
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And in 2021, the FDA under President Joe Biden allowed online prescribing and mail-order delivery of mifepristone, which expanded further access.
In 2024, the Supreme Court declined to restrict access to mifepristone in the wake of Roe v. Wade being overturned, but the high court’s decision did allow for future policy changes.
Mifepristone access limited in states
Dig deeper:
The Associated Press reported that access to mifepristone is limited in large parts of the U.S. because of state laws that ban abortion — like medication abortion — or enforce separate restrictions on the drug’s use.
The Source: Information for this story was provided by the Associated Press, which obtained an email from the FDA about the approval of mifepristone. This story was reported from Washington, D.C.