Public Citizen urges FDA to ‘immediately’ withdraw drug for preventing premature birth
A consumer advocacy group is urging the FDA to immediately withdraw Makena because it failed a confirmatory study.
As an Oct. 29 regulatory meeting nears to review the Makena treatment for preventing premature births, a consumer advocacy group is urging the Food and Drug Administration to immediately withdraw the controversial drug because it failed a confirmatory study.
In a being filed with the FDA on Tuesday, Public Citizen pointed to a required followup that was released in March, showing Makena is no better than a placebo in preventing preterm birth or major complications from preterm birth. The advocacy group also argued the agency erred when
