FDA pushing Makena, early drug pricing target, off the market

FDA has proposed the withdrawal of AMAG’s Makena, sending the drug, and the women who have counted on it to prevent premature births, into what could be the final turn in a roller-coaster ride that started with its approval in 2011.

Monday’s proposal from FDA’s Center for Drug Evaluation and Research (CDER) is not final; Makena hydroxyprogesterone will remain on the market until the FDA commissioner orders its removal or until AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) and sponsors of generic versions elect to withdraw the product...