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Bookmark or Share- Makena® (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 ®. FDA has stated that it recognizes that a limited supply of these drugs has already been distributed, including to physicians’ offices and pharmacies.
- Makena Uses, Dosage & Side Effects - Drugs.comWhat is Makena? Makena is a form of progestin, a manmade form of a female hormone called progesterone. Makena is used to lower the risk of premature birth in a woman who has already had one premature baby. Makena will not stop premature labor that has already begun.
- Preterm Birth Drug Withdrawn After 12 Years - The New York TimesPublished March 7, 2023 Updated March 8, 2023. The company that makes Makena, the only drug aimed at preventing preterm birth, announced on Tuesday that it was voluntarily pulling the medication...
- FDA Commissioner and Chief Scientist Announce Decision to Withdraw ...April 06, 2023. Español. Today, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena—a drug that had been approved under the accelerated approval...
- FDA takes only drug for premature birth off the market | CNNCNN — 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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