FDA Chooses to Withdraw Approval for Premature Birth Drug Makena

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The FDA’s move to withdraw hydroxyprogesterone caproate injection (Makena) was a joint decision by both the FDA’s Commissioner and its Chief Scientist.

An announcement was made by the U.S. Food and Drug Administration (FDA) that the agency's approval of hydroxyprogesterone caproate injection (Makena, Covis Pharma Group)—a drug designed to help reduce pregnant mothers’ risk of preterm birth—would be withdrawn.1

Before the decision, hydroxyprogesterone caproate injection had been the only treatment with FDA-approval for reduction of preterm birth risk for pregnant women with prior histories of spontaneous preterm birth.

“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes—particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” stated FDA Commissioner Robert M. Califf.

The premature birth drug had been granted FDA-approval through an accelerated approval pathway in 2011, before the new decision that was jointly issued by the FDA’s Chief Scientist and by Califf, the FDA’s Commissioner.

The accelerated pathway had been based upon the decision that the drug’s sponsor could show the treatment’s effects on “an intermediate clinical endpoint that was reasonably likely to predict clinical benefit,” the FDA announcement notes.

The approval maintained a requirement that Covis Pharma would enact a post-marketing confirmatory study, according to the FDA. The results could not provide verification of clinical benefits.

A hearing was then conducted in October of 2022 following the FDA’s Center for Drug Evaluation and Research (CDER) proposal to withdraw approval in the year 2020. As of today, the drug and its generic versions are not approved any longer and cannot be legally distributed in the world of interstate commerce.

The FDA’s Chief Scientist, Namandjé Bumpus, PhD, noted the “serious problems of preterm birth with respect to both maternal and neonatal health and the contribution of institutional forces that have led to health disparities, including preterm birth, among Black women.”

Nevertheless, she added that the FDA’s opinion was not intended to minimize such concerns, and that “to the contrary, our hope is that this decision will help galvanize further research.”


  1. FDA Commissioner and Chief Scientist announce decision to withdraw approval of Makena. FDA. April 6, 2023. Accessed April 6, 2023.