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BRIEF-Novo Nordisk resubmits new drug application for fast-acting insulin aspart in the U.S
March 29, 2017 / 3:00 PM / in 5 months

BRIEF-Novo Nordisk resubmits new drug application for fast-acting insulin aspart in the U.S

March 29 (Reuters) - Novo Nordisk

* Says has resubmitted the new drug application (NDA) for fast-acting insulin aspart as a class II re-submission to the United States Food and Drug Administration (FDA)

* Says FDA requested in October 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

* Says has now evaluated the content of the Complete Response Letter and completed the End-of-Review meeting with FDA

* Says expects to receive feedback from FDA in last quarter of 2017 Source text for Eikon: Further company coverage:

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