In a defiant move, AMAG Pharmaceuticals (AMAG) 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 reached the same conclusion and recommended that the drug — which has been a standard of care across the U.S. since it was approved nine years ago — should be withdrawn.
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