FDA Finally Approves Evita's Generic Mifepristone After Four-Year Wait
Evita Solutions has finally received FDA approval for its generic version of mifepristone, four years after initially applying. This abortion pill, when taken with misoprostol, is used in roughly two-thirds of U.S. abortions. The approval has sparked controversy, with anti-abortion groups and politicians voicing opposition.
The FDA's approval process for Evita Solutions' application took longer than usual, with the agency typically approving such applications within 10 months. In 20X4, Genpharm also submitted an application for a generic version of mifepristone. Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary have promised a thorough review of mifepristone's safety.
Students for Life Action has condemned the approval, describing it as 'a stain on the Trump presidency'. Senator Josh Hawley of Missouri has also criticized the move, expressing a lack of confidence in the FDA's leadership. Evita Solutions, however, aims to provide safe, affordable, and compassionate abortion care.
The FDA's approval of Evita Solutions' generic mifepristone is a regulatory formality that has triggered debate. While the company seeks to enhance access to safe abortion care, opponents argue against the move. The FDA, maintaining neutrality, has limited discretion in deciding whether to approve a generic drug.
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