AMAG Pharmaceuticals, Inc. announced that it has formally requested a public hearing in response to the U.S. Food and Drug Administration’s (FDA) proposal to withdraw its approval of Makena®, the only FDA-approved treatment, along with its equivalent generics, to reduce preterm birth. Makena was approved in 2011, based on the landmark NICHD MFMU trial by Meiset al. A second, FDA-required trial (PROLONG) predominantly enrolled women outside of the U.S., in countries with markedly lower rates of preterm birth. The PROLONG trial did not show a difference between treatment and vehicle arms with respect to preterm birth or neonatal outcome. However, maternal and fetal safety was re-affirmed.