FDA's CDER proposes market withdrawal of hydroxyprogesterone
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FDA’s CDER proposes market withdrawal of hydroxyprogesterone Following the failure of a required confirmatory postmarketing study to confirm the clinical benefit of hydroxyprogesterone caproate injection [Makena; AMAG Pharmaceuticals], the US FDA’s Center for Drug Evaluation and Research (CDER) has concluded that current evidence does not demonstrate its effectiveness for its approved use, and has proposed the withdrawal of the drug from the market. In 2011, based on results of a single trial, the FDA had granted Makena accelerated approval for reducing the risk of preterm birth in women with a previous spontaneous preterm birth, on the condition that the drug company conducted a trial to confirm the benefit of the drug in neonates. Makena and approved generic versions of hydroxyprogesterone will remain on the market in the US until the manufacturers decide to remove their products from the market or the FDA Commissioner mandates their removal. The Commissioner will determine whether to hold a public hearing, if requested by AMAG Pharmaceuticals, and after the hearing will make a decision on whether to withdraw approval of Makena and approved generic equivalents. Until a final decision is made on the marketing status of the drug, the FDA recommends that healthcare professionals discuss the risks and benefits of Makena with patients in deciding whether to use the drug. FDA. CDER proposes withdrawal of approval for Makena. Internet Document : 5 Oct 2020. Available from: URL: https://www.fda.gov/drugs/drug-safety-and-availability/ 803507711 cder-proposes-withdrawal-approval-makena
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Reactions 17 Oct 2020 No. 1826
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