Claims Challenging Efficacy of Preterm Birth Drug Preempted, N.J. Federal Judge Rules

NEWARK, N.J. — A New Jersey federal judge has dismissed a lawsuit accusing AMAG Pharmaceuticals Inc. of misrepresenting the efficacy of its preterm birth drug Makena, finding the plaintiffs failed to support their claims that the drug maker had “newly acquired information” warranting a post-approval label change.

In a May 25 order, Judge John M. Vazquez of the U.S. District Court for the District of New Jersey allowed plaintiffs to file an amended complaint within 30 days.

AMAG Pharmaceuticals Inc. holds the rights to market and sell Makena (hydroxyprogesterone caproate). The drug was originally marketed under the brand name Delalutin …