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Novo edges closer to Tresiba approval

Novo Nordisk has moved one step closer to gaining approval of its diabetes drug Tresiba on the US market, as the FDA has accepted the company’s resubmitted application for review.

Foto: Novo Nordisk

The US Food and Drug Administration (FDA) has accepted for review the Class II Resubmissions for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart), Novo Nordisk writes in a press release.

To preserve the integrity of the ongoing DEVOTE trial, only a small team within Novo Nordisk has access to the data. This team has prepared the interim analysis for the Class II resubmission and will interact with the FDA during the review, on matters related to the interim analysis.

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