WASHINGTON (NEWSnet/AP) — The maker of an unproven drug intended to prevent premature births says it will voluntarily remove the product from the U.S.

It comes after the Food and Drug Administration signaled plans to force it out.

The drug, Makena, is a synthetic version of the hormone progesterone, which is needed to maintain a pregnancy. It’s the only drug with FDA approval to reduce the risk of premature birth.

The removal of Covis Pharma's drug comes roughly four years after Makena failed to show a benefit in helping mothers carry to term.

Since then the Food and Drug Administration has been moving to get the drug off the market, though Covis has repeatedly appealed for more time to conduct additional research.

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