• STAT Plus: A defiant AMAG wants an FDA hearing rather than withdraw its premature birth drug

    5 days ago - By STAT

    In a defiant move, AMAG Pharmaceuticals is refusing to voluntarily withdraw its controversial treatment for preventing premature births, despite a request to do so made earlier this month by the Food and Drug Administration. Instead, the drug maker is seeking a hearing to review the rationale given by the regulator for wanting its Makena medication pulled off the market.
    The agency explained that a required post-marketing study had failed to verify a clinical benefit and that available evidence does not show Makena is effective for its approved use. A year ago, an FDA advisory panel...
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