FDA Forces the Only Drug for Preterm Births to Leave Market

The only drug on the market to help prevent preterm births must stop being sold immediately, a move that comes after scientists at the Food and Drug Administration earlier determined it was ineffective.

The FDA said Thursday it is withdrawing its approval for the drug Makena and its generics because the drugs no longer are shown to be effective and the benefits don’t outweigh the risks. Makena, as well as its generics, can no longer be lawfully distributed in interstate commerce.