The U.S. Food and Drug Administration (FDA) has approved a generic version of mifepristone, marking the second such drug to enter the market. On Tuesday, the agency notified Evita Solutions that its application met regulatory standards for approval. The decision comes as pro-life advocates condemn the move, citing concerns over safety and ethical implications.

The FDA’s letter to Evita Solutions stated the generic mifepristone tablets are “therapeutically equivalent” to the brand-name version, Mifeprex, which has been available since 2000. The drug is typically used in combination with misoprostol for medication abortions, a procedure accounting for nearly two-thirds of all abortions in the U.S.

Evita Solutions, the company behind the generic formulation, highlighted its mission to “normalize abortion care” and ensure accessibility. However, critics argue the approval undermines public health safeguards. Sen. Josh Hawley (R-MO) denounced the decision, calling it “shocking” and accusing the FDA of ignoring evidence of risks to mothers. He criticized the agency’s leadership, stating, “I have lost confidence in the leadership at FDA.”

Recent efforts by Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to revise safety protocols for mifepristone sparked further controversy. Marjorie Dannenfelser of Susan B. Anthony Pro-Life America called the approval “unconscionable,” alleging the drug endangers lives and undermines state-level pro-life laws. Anti-abortion groups have continued urging federal intervention to restrict access to abortion pills.