FDA removes Makena from market over lack of efficacy evidence.

The FDA has withdrawn its approval for Makena, a drug intended to prevent premature births, after studies showed it wasn't effective. Makena and its generics can no longer be distributed in interstate commerce. Preterm birth rates are highest for Black infants compared to other racial and ethnic groups, and there is no other approved treatment for preventing preterm birth. Covis Pharma, the drugmaker, had previously said it would pull Makena voluntarily, but the FDA rejected that proposal.