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FDA Approves Novo Nordisk’s Ozempic to Cut Cardiovascular Risk

Jan. 16, 2020, 10:46 PM

FDA approves label expansion for Ozempic, Novo Nordisk says.

  • Ozempic approved for indication of reducing risk of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease
  • Approval based on results of a cardiovascular outcomes trial which showed Ozempic produced statistically significant reduction in risks of CV death vs placebo
  • FDA also updated the label for Rybelsus to include additional information from a cardiovascular outcomes trial to reflect CV safety
  • NOTE: Nov. 1, Novo Sales Outlook Edges Higher as New Diabetes Drug Surges

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Jim Silver in New York at...

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