Preterm birth drug, Makena, withdrawn from market

(CNN) – The U.S. Food and Drug Administration has announced its final decision to withdraw approval of Makena, a drug meant to reduce the risk of premature birth.

Makena was approved more than a decade ago.

The FDA says the drug is not effective and the benefits of taking it do not outweigh the risks.

Generic versions of the drug are also no longer approved.

This means Makena and its generics cannot lawfully be distributed in interstate commerce.

Covis Pharma, the maker of the drug, said Tuesday it was moving to withdraw the medication from the market after the FDA said it is not effective.