FDA refuses to file Novo Nordisk application

The FDA has refused to start filing Novo Nordisk's application for an expanded marketing authorization for Ozempic in a higher dose.

Photo: Novo Nordisk Pharmatech/PR

Novo Nordisk has received a Refusal to File letter from the US Food and Drug Administration (FDA) for its application for a version of Ozempic, which Novo Nordisk announces on Monday evening.

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