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Post Market Regulation & Studies Review Pathway Regulation

Accelerated Approval: Midodrine Experience Shows Regulatory Challenge US FDA Faces With Makena

  • Analysis

Executive Summary

The orthostatic hypotension treatment midodrine has been on the market for more than 20 years despite the failure of postmarketing studies to confirm clinical benefit; an advisory committee soon will weigh the future of AMAG’s preterm birth drug Makena, which failed its confirmatory trial required as a condition of accelerated approval.


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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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