29 March 2017 - Novo Nordisk today announced that the company has resubmitted the new drug application for fast-acting insulin aspart as a class II re-submission to the US FDA.

In October 2016, Novo Nordisk announced that it had received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (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 CRL 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.

Read Novo Nordisk press release