Novo Nordisk: FDA Accepts For Review Class II Resubmissions For Tresiba, Ryzodeg

April 8, 2015 1:05 AM

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(RTTNews.com) - Novo Nordisk ( NVO ) said that the US Food and Drug Administration has accepted for review the Class II Resubmissions for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart).

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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