The Federal Drug Administration (FDA) has approved a generic version of mifepristone, marking the second such drug to enter the U.S. market. The agency informed Evita Solutions in a letter that its application met regulatory requirements, enabling the drug’s distribution. Mifepristone is typically used in conjunction with misoprostol to induce abortions, a method accounting for nearly two-thirds of all procedures in the country.

Senator Josh Hawley (R-MO) criticized the decision, calling it “shocking” and accusing the FDA of ignoring risks associated with chemical abortion drugs. He stated the agency had pledged to review safety protocols but instead approved new formulations, expressing lost confidence in its leadership. Pro-life advocates condemned the move, with Marjorie Dannenfelser of Susan B. Anthony Pro-Life America calling it “unconscionable” and citing dangers to women, minors, and unborn lives.

Evita Solutions emphasized its commitment to making abortion care accessible, describing its mission as normalizing the procedure. The FDA’s approval came amid ongoing debates over mifepristone’s safety, with recent calls to revise risk mitigation strategies sparking further controversy.