FDA Requests Withdrawal Of Makena And Generics
Hydroxyprogesterone Withdrawal Request Goes Beyond Failed Confirmatory Trial
Executive Summary
Preterm birth prevention drug should come off the market to ensure the accelerated approval pathway does not operate as a lower approval standard, agency says; proposed withdrawal comes almost a year after an advisory committee split on the question of whether Makena should stay on the market in light of delayed, and ultimately unsuccessful, confirmatory study.