After authorizing Makena, a hydroxyprogesterone caproate injection, under an accelerated approval pathway in 2011, the US Food and Drug Administration (FDA) has pulled approval for the drug. “[T]he touchstone of FDA drug approval is a favorable benefit-risk assessment,” FDA Commissioner Robert M. Califf, MD, said in a statement. “[W]ithout that favorable assessment, the drug should not have the status of being FDA-approved.”
Source: JAMA Online First