AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced today 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 Meis et al . A second, FDA-required trial ( PROLONG ) predominant
October 14, 2020
· 6 min read