A medicine designed to prevent preterm births has been found to be ineffective, according to federal health experts, opening the way for US regulators to proceed with a long-delayed campaign to remove it from the market. In case of FDA panel backs removal of unproven pregnancy drug.
In spite of requests from the maker to keep the injectable medicine Makena available for more study, the advisory council for the Food and Drug Administration decided 14-1 on Wednesday that it should be discontinued.
In general, the experts supported an FDA judgment from 2020 that declared the medicine useless and demanded its withdrawal. This week's unusual public hearing was brought on by the manufacturer, Covis Pharma, who had contested the ruling.
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