Makena Will Get Extended Time On Market, Even If AMAG’s Appeal Fails

AMAG’s decision to fight US FDA’s decision to pull the preterm birth product seems unlikely to result in victory, but Makena will get to stay on the market during the appeal process, which is expected to be protracted and will likely include accusations that the agency is being insensitive to affected patients.

AMAG Pharmaceuticals Inc.’s strategy to keep its preterm birth treatment Makena on the US market seems three-fold: raise process concerns with the FDA, rally the product’s allies, and request extensions.

Makena (hydroxyprogesterone caproate injection, also known as HCP or 17P) is slated for removal after the FDA concluded that it...