STAT+: Controversial drug for premature birth is withdrawn by manufacturer after battle with FDA
After months of anticipation, the manufacturer of a controversial drug for premature births has agreed to withdraw its treatment, capping an unusual battle with the U.S. Food and Drug Administration over its authority to have medicines removed from the market.
The drug in question, called Makena, was approved more than a decade ago and quickly generated a firestorm over its cost. More recently, though, its effectiveness was thrown into doubt after results of a required follow-up clinical trial failed to verify a benefit. But the company that sells the treatment, Covis Pharma, fought a request by the FDA to withdraw the drug.
