Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA

AMAG Pharmaceuticals Inc. has laid out its case for keeping Makena (hydroxyprogesterone caproate) on the market under accelerated approval while it conducts retrospective and observational studies, and possibly even another randomized, placebo-controlled trial, of the drug for preventing recurrent preterm birth.

In a recent submission to the US Food and Drug Administration, AMAG presents its most publicly detailed proposals to date for additional confirmatory studies