FDA removes only preterm birth drug from market over lack of efficacy proof
TL;DR Summary
The FDA is withdrawing its approval of Makena, the only drug on the market for reducing the risk of preterm birth in pregnant women, due to a lack of effectiveness demonstrated by the treatment. Covis Pharma, the maker of Makena, will make a last-ditch effort to keep its medication on the market in October 2022. There are currently no approved treatments for preterm birth.
- FDA pulls approval for only drug meant to reduce preterm birth The Hill
- FDA takes only drug for premature birth off the market CNN
- FDA pulls Makena from market, saying company didn't prove it works : Shots - Health News NPR
- FDA yanks approval of Makena, only drug cleared to lower preterm birth The Washington Post
- FDA forces unproven premature birth drug Makena off market ABC News
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