Follow-up Comments to the FDA Regarding CDER’s Proposal to Withdraw Approval of Makena (Hydroxyprogesterone Caproate)

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In follow-up comments to the Food and Drug Administration regarding the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena (hydroxyprogesterone caproate) for prevention of preterm labor, Public Citizen urged the agency to take prompt regulatory action as soon as the approval of Makena is withdrawn to prevent the predictable pharmacy compounding of hydroxyprogesterone caproate for prevention of preterm birth.

See Public Citizen’s other work on hydroxyprogesterone caproate (Makena).