FDA approves new generic version of chemical abortion drug mifepristone

"FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution," Hawley said. "I have lost confidence in the leadership at FDA."

Published: October 2, 2025 3:27pm

Updated: October 2, 2025 3:48pm

The Food & Drug Administration (FDA) has quietly approved a new generic version of the chemical abortion drug mifepristone, prompting backlash from conservatives. 

The FDA sent a letter approving the drug to its manufacturer, Evita Solutions LLC, stating that it has reviewed the drug and found that it meets the requirement for approval under the Federal Food, Drug, and Cosmetic Act.

The drug was approved on Tuesday, but the approval was not reported until Thursday. The company said the drug is effective for carrying out early abortions within the first 70 days of the woman's last menstrual cycle.

Missouri Republican Sen. Josh Hawley on Thursday said he has "lost confidence" in FDA leadership after the agency approved the drug, stating that chemical abortion drugs are "dangerous and even deadly for the mother."

"FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution," Hawley wrote. "I have lost confidence in the leadership at FDA."

The FDA approval comes after the Department of Health and Human Services said last month that it would conduct a study on the real-world harms of chemical abortion drugs. 

The FDA has not publicly commented on Hawley's criticism of the new drug so far.

Misty Severi is a news reporter for Just The News. You can follow her on X for more coverage.

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