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Novo Nordisk resubmits higher-dosage Ozempic application to the FDA

After Novo Nordisk's previous FDA application was returned due to missing data, the firm has resubmitted a label expansion application for Ozempic on the world's largest market for diabetes products.

Photo: Stine Tidsvilde

On Friday, Novo Nordisk announced in a company statement that it has once again applied to the US Food and Drug Administration (FDA) for permission to start marketing the weekly diabetes treatment Ozempic in a higher dosage.

In February, the FDA declined to start processing a previous application since the health authority lacked information on factors such as a new production facility before granting the necessary approvals. Instead, the FDA sent a Refusal to File Letter in March.

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