FDA Forces the Only Drug for Preterm Births to Leave Market

📆 7/04/2023 3:00 AM
📰 WSJ

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The only drug approved by the FDA to prevent preterm births will longer be available. The agency said it is withdrawing its approval for the drug Makena due to its ineffectiveness.

The FDA typically nudges manufacturers to withdraw drugs voluntarily; it is rare for the agency to force a drug withdrawal.Updated April 6, 2023 10:46 am ET

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 AdministrationThe 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.

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