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1. Makena® (hydroxyprogesterone caproate injection)
Link: https://makena.com/
Description: Web ResultMakena® (hydroxyprogesterone caproate injection) On April 6, 2023, the U.S. Food and Drug Administration (FDA) issued a final decision ordering the withdrawal of the approval of Makena ®.
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2. Makena (hydroxyprogesterone caproate injection) Information
Link: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information
Description: Web ResultApr 6, 2023 · FDA CDER proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market because the required postmarket study failed to verify clinical benefit and we have concluded...
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3. FDA takes only drug for premature birth off the market | CNN
Link: https://www.cnn.com/2023/04/06/health/makena-fda-withdrawl/index.html
Description: Web ResultApr 6, 2023 · CNN — On Thursday, the US Food and Drug Administration announced its final decision to withdraw its approval of Makena, a drug approved more than a decade ago to reduce the risk of preterm birth...
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4. Preterm Birth Drug Withdrawn After 12 Years - The New York Times
Link: https://www.nytimes.com/2023/03/07/health/preterm-birth-drug-makena-fda.html
Description: Web ResultMar 7, 2023 · The company that makes Makena, the only drug aimed at preventing preterm birth, announced on Tuesday that it was voluntarily pulling the medication off the market after advisers for the Food and...
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5. Maker of preterm birth drug Makena to withdraw it from market
Link: https://www.cnn.com/2023/03/08/health/makena-preterm-birth-withdrawn-covis/index.html
Description: Web ResultMar 8, 2023 · CNN — The maker of the drug Makena, which was approved more than a decade ago to reduce the risk of preterm birth, said Tuesday that it is moving to withdraw the medication from the market after...
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6. FDA pulls Makena from market, saying company didn't prove it …
Link: https://www.npr.org/sections/health-shots/2023/04/06/1167919912/fda-pulls-the-only-approved-drug-for-preventing-premature-birth-off-the-market
Description: Web ResultApr 6, 2023 · Manuel Balce Ceneta/AP. The Food and Drug Administration is pulling its approval for a controversial drug that was intended to prevent premature births, but that studies showed wasn't effective....
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7. FDA advisers vote to recommend preterm birth drug Makena be …
Link: https://www.cnn.com/2022/10/19/health/makena-preterm-birth-fda-advisers/index.html
Description: Web ResultOct 19, 2022 · AP. CNN — A US Food and Drug Administration advisory committee voted Wednesday that a drug approved more than a decade ago to reduce the risk of preterm birth should not be allowed to remain on the...
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8. Withdrawing Approval of Makena — A Proposal from the FDA …
Link: https://www.nejm.org/doi/full/10.1056/NEJMp2031055
Description: Web ResultFeb 29, 2024 · On October 5, 2020, the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) proposed withdrawal of approval of Makena (hydroxyprogesterone caproate...
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9. US mothers face uncertainty as lone, unproven drug for preterm …
Link: https://www.theguardian.com/us-news/2023/mar/23/makena-premature-birth-drug-pulled-us-reaction
Description: Web ResultMelody Schreiber. Thu 23 Mar 2023 06.00 EDT. Makena is the only drug approved specifically to prevent premature birth, a major health issue facing children and families, in the US.
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10. FDA pulls Makena from pharmacies, saying it has no benefits
Link: https://www.latimes.com/business/story/2023-04-06/fda-pulls-makena-preterm-birth-drug-from-pharmacies
Description: Web ResultApr 6, 2023 · Business. FDA pulls only drug for preterm births, saying it has no benefit. The FDA ordered Makena be pulled from pharmacies on Thursday, saying the drug had no benefit for pregnant women. AMAG...