Only Preterm Birth Drug in US Pulled From Market, FDA Says (1)

The only drug approved in the US to reduce the risk of premature birth will be immediately pulled from the market due to a lack of effectiveness, after manufacturer Covis Pharma Group had pushed for a gradual withdrawal.

“After thoroughly reviewing the record for this matter, we have determined that there is an insufficient demonstration of effectiveness to balance any level of risk.” the Food and Drug Administration, said in a statement. Last month, the agency’s staff recommended immediate withdrawal of Makena and its generic equivalents as the treatment “unnecessarily exposes patients to only risks.”

The action is the ...