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FDA Officially Withdraws Makena, the Only Preterm Birth Med
April 7th 2023Issued jointly by the FDA Commissioner and Chief Scientist, the decision means Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce. At the same time, the agency “recognizes that there is a supply of product that has already been distributed.”
FDA Grants Emergency Use Authorization to Gohibic for Critically Ill COVID-19 Patients
April 6th 2023The FDA granted the EUA based on the PANAMO phase 3 clinical trial results demonstrating that vilobelimab improved survival compared to placebo, with a 23.9% relative reduction in all-cause mortality at 28 days.
FDA Greenlights Generic Leukemia Treatment
March 10th 2023Other news includes the launches of the first generic of an ulcer drug, the antipsychotic lurasidone, an extended-release version of topiramate for migraine, and additional strengths of the cancer drug lenalidomide. Additionally, Glenmark will distribute Cediprof's generic Adderall, and the FDA has accepted Amneal’s application for a generic naloxone nasal spray.