The U.S. Food and Drug Administration has approved a second generic version of the abortion pill mifepristone, a move expected to increase supply amid ongoing legal challenges to reproductive healthcare access.
October 2, 2025
Source:
NPR
FDA Greenlights Second Generic Mifepristone
The U.S. Food and Drug Administration (FDA) has officially approved a generic version of mifepristone from manufacturer Evita Solutions. This decision marks a significant development in the landscape of abortion access in the United States.
The approval makes Evita Solutions the third manufacturer of the key abortion medication for the U.S. market, joining Danco Laboratories, which produces the brand-name Mifeprex, and GenBioPro, which introduced the first generic in 2019.
Mifepristone is the first of two drugs used in a medication abortion regimen, which accounts for the majority of abortions in the country. It works by blocking the hormone progesterone, which is essential for sustaining a pregnancy.
The new generic is expected to enter the market in January 2026, a timeline that could bolster the drug's supply chain amid intense legal and political battles over its availability.
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Source:
AP News
Regulatory Pathway and Safety Protocols
The approval was granted through the FDA's Abbreviated New Drug Application (ANDA) process, a standard pathway for generic medications.
The ANDA Process
Under the ANDA process, a manufacturer is not required to conduct new clinical trials. Instead, it must demonstrate that its product is bioequivalent and therapeutically equivalent to the original brand-name drug. This ensures the generic is just as safe and effective as the version that has already been studied extensively.
Mifepristone REMS Program
To manage the drug's safety, Evita Solutions' generic will be subject to the established Mifepristone Risk Evaluation and Mitigation Strategy (REMS) program. This FDA-mandated program includes specific requirements, known as Elements to Assure Safe Use (ETASU), for prescribing and dispensing the medication safely.
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Source:
AP News
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