CDER proposes withdrawal of approval for Makena

CDER proposes withdrawal of approval for Makena

Source: 
FDA
snippet: 

Last week,  the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market because the required postmarket study failed to verify clinical benefit and we have concluded that the available evidence does not show Makena is effective for its approved use.