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FDA removes only preterm birth drug from market

1 min read
Source: NBC News
FDA removes only preterm birth drug from market
Photo: NBC News
TL;DR

The FDA has ordered the immediate withdrawal of Makena, a drug intended to prevent premature births, after data showed it doesn't help pregnant women. Swiss drugmaker Covis Pharma had repeatedly tried to keep the drug on the market while conducting additional studies, but the FDA rejected this proposal. Makena was the only drug approved in the US to help reduce the risk of early births in women with a history of preterm deliveries. The injectable drug is a synthetic version of the hormone progesterone, which helps the uterus sustain pregnancy.

Topics:businesshealth#covis-pharma#drug-withdrawal#fda#health#makena#premature-birth
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  1. FDA forces unproven premature birth drug Makena off market  NBC News
  2. FDA pulls the plug on Covis' troubled preterm birth med Makena  FiercePharma
  3. FDA pulls Makena approval, leaves patients without preterm birth treatment  Axios
  4. FDA takes only drug for premature birth off the market  KCCI Des Moines
  5. Drug aimed at preventing pre-term birth is pulled off the market  WFAA

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