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3 lis 2020 · 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...
The FDA initiated this analysis to better understand utilization of hydroxyprogesterone caproate (HPC) injection, including Makena® and its generics, among pregnant women in the United States. We identified 3,445,739 live-birth pregnancies (among 2.9 million women) between 2008 and 2018 in the Sentinel Distributed Database (SDD).
The FDA Struggle to Withdraw Makena: Problems With the Accelerated Approval Process. Hydroxyprogesterone caproate (Makena) is an injectable drug for the prevention of preterm birth, ie, birth prior to 37 weeks of gestation.
17 maj 2024 · Following a controversy over Covis’ preterm birth drug Makena in the U.S. last year, the European Medicines Agency (EMA) is cracking down on hydroxyprogesterone caproate therapies across the pond.
6 kwi 2023 · Following years of back-and-forth between the agency and the drugmaker Covis Pharma, the FDA's decision came suddenly Thursday. It means the medication, Makena, and its generics are no longer ...
25 mar 2022 · By Christina Jewett. March 25, 2022. By the time Brittany Bonds gave birth to her third son in the back of an ambulance 10 weeks before he was due, she no longer trusted the drug Makena. The drug...
6 kwi 2023 · 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 that...
