FDA pulls approval for only drug meant to reduce preterm birth ...Middle East

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FDA pulls approval for only drug meant to reduce preterm birth
The Food and Drug Administration (FDA) is pulling its approval of the only drug on the market for reducing the risk of preterm birth in pregnant women, citing a lack of effectiveness demonstrated by the treatment. The FDA approved Makena in 2011 under its accelerated approval pathway as a treatment for reducing the risk of preterm birth in women pregnant with one child and who have a history of spontaneous preterm birth. At the time of the approval, the FDA stipulated that a confirmatory study be conducted following approval. This study subsequently failed to confirm clinical benefits of Makena in reducing the risk of preterm births. The FDA's Center for Drug Evaluation and Researc

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