The Food and Drug Administration (FDA) has proposed that Makena (hydroxyprogesterone caproate injection; AMAG Pharmaceuticals) be withdrawn from the market because the required post-market study failed to verify clinical benefit, and the available evidence does not show Makena is effective for its approved use.

Makena was granted accelerated approval in 2011 by the FDA to reduce the risk of preterm birth in women who previously had a spontaneous (unexplained) preterm birth, which is delivery of a baby before 37 weeks. As part of this accelerated approval, the company was required to conduct a clinical trial to confirm the drug provided clinical benefit to newborns. The required confirmatory trial failed to show that Makena is effective for improving the health of babies born to women with a history of unexplained preterm birth, and the available evidence does not demonstrate that Makena reduces the risk of preterm birth. Therefore, the FDA’s Center for Drug Evaluation and Research (CDER) has proposed that Makena be withdrawn from the market and has issued a notice of opportunity for a hearing to AMAG Pharmaceuticals.

Makena and its approved generic equivalents will remain on the market until the manufacturers decide to remove the drugs or the FDA Commissioner mandates their removal.

Food and Drug Administration (FDA). CDER proposes withdrawal of approval for Makena [news release]. October 5, 2020. Available at: click here. Accessed October 7, 2020.