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Novo-Nordisk DK0060534915

Novo Nordisk Resubmits NDA For Fast-acting Insulin Aspart In US

03/29/17

WASHINGTON (dpa-AFX) - Novo Nordisk (NVO) said that it has resubmitted the new drug application (NDA) for fast-acting insulin aspart as a class II re-submission to the US Food and Drug Administration.

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In October 2016, Novo Nordisk announced that it had received a Complete Response Letter from the FDA regarding the NDA for fast-acting insulin aspart.

In the letter, the FDA requested additional information related to the assay for the immunogenicity and the assay used to generate the clinical pharmacokinetics data before the review of the NDA could be completed. Novo Nordisk has now evaluated the content of the Complete Response Letter and completed the End-of-Review meeting with FDA; based on this, Novo Nordisk has resubmitted the fast-acting insulin aspart NDA as a class II re-submission.

Novo Nordisk expects to receive feedback from the FDA in the last quarter of 2017.

Copyright RTT News/dpa-AFX


                                                                                                                        

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