The final call on whether Covis Pharma’s preterm birth prevention drug Makena (hydroxyprogesterone caproate) stays on the US market or is withdrawn will be made jointly by two senior Food and Drug Administration officials at least three months after the 17-19 October public hearing.
The Makena Deciders: FDA Commissioner Califf, Chief Scientist Bumpus To Jointly Make Final Call On Drug’s Fate
The two senior agency officials will render the decision together as co-signatories on whether Makena loses its accelerated approval or is allowed to stay on the market; that decision will not come before mid-January, and is likely to be weeks or months later, based on a timeline set out by hearing officer Celia Witten.
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