FDA removes sole premature birth drug from market.

The FDA has withdrawn its approval of Makena, the only drug approved more than a decade ago to reduce the risk of preterm birth, stating that it is not effective and that the benefits of taking it do not outweigh the risk. The maker of the drug, Covis Pharma, said it was moving to withdraw the medication from the market after an FDA panel said it is not effective. The FDA recognizes that there is a supply of product that has already been distributed and said patients who have questions should talk to their healthcare provider.