Public Citizen’s Petition to Withdraw Drug for Preventing Premature Birth
By By Ed Silverman
In a recent article, STAT highlights Public Citizen’s petition that was filed with FDA to ‘immediately’ withdraw drug Makena for preventing premature birth. “In a citizen’s petition being filed with the FDA on Tuesday, Public Citizen pointed to a required follow up effectiveness study that was released in March, showing Makena is no better than a placebo in preventing preterm birth or major complications from preterm birth.”
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