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
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