FDA’s Makena Withdrawal Needs Clear Plan, Analysts Say (1)

The FDA’s notice to pull the only preterm birth drug approved in the US lacks clarity in how the drug center will approach the existing drug supply, and what happens next for patients currently taking the treatment, health providers and analysts said.

The Food and Drug Administration on Thursday announced it would immediately rescind approval of the preterm birth drug Makena after months of review by FDA Commissioner Robert M. Califf and Chief Scientist Namandjé Bumpus. The decision moves more swiftly than what the manufacturer, Covis Pharma, proposed last month. The FDA’s decision applies both to the brand-name Makena and ...