Preterm birth prevention drug Makena was officially pulled from the market 5 April, more than four years after the drug’s confirmatory trial required as a condition of accelerated approval failed. But thanks to a degree of deference by US Food and Drug Administration Commissioner Robert Califf and Chief Scientist Namandje Bumpus, Covis Pharma’s branded product and generic versions of the drug could linger on the market for a bit longer and compounding of the active ingredient may be possible longer-term.
Califf and Bumpus directed the Center for Drug Evaluation and Research to determine the next steps to implement their decision...
