AMAG Files Response to Citizen Petition
(WorldNews Health)

Today, AMAG Pharmaceuticals, Inc. submitted its response https://www.regulations.gov/document?D=FDA-2019-P-4683-0005 with the U.S. Food and Drug Administration (FDA) to a petition filed by Public Citizen`s Health Research Group (HRG). AMAG respectfully disagrees with HRG`s request to withdraw FDA approval of Makena® (hydroxyprogesterone caproate injection) and the five FDA-approved generics (which could no longer be marketed if Makena`s NDA was withdrawn). The response provides six arguments to support the continued, positive benefit-risk profile of Makena. Preterm Birth is a Significant Public Health Issue Preterm birth is the leading cause of neonatal mortality and morbidity in the U.S.,...