FDA adcomm again votes to pull controversial pre-term birth drug from the market
The FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee of outside experts voted 14-1 to pull Covis Pharma’s controversial preterm birth drug from the market after its confirmatory trial from 2018 failed to confirm the drug’s benefit for babies or mothers.
First approved under the accelerated approval pathway in 2011, the injection came before a nearly 3-day saga, resulting in a swift and almost unanimous vote to pull Makena.
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