BRIEF-Novo Nordisk says U.S. FDA requests more information on faster-acting insulin aspart

October 8, 2016 8:37 AM

1 0

* Says Novo Nordisk received complete response letter from U.S. Food and Drug Administration (FDA) regarding New Drug Application for faster-acting insulin aspart.

* Says FDA requests additional information related to analysis of immunogenicity and clinical pharmacology data before review of New Drug Application can be completed.

Also read: National Cancer Institute Says Researchers Didn’t Quickly Tell FDA After Two Deaths in a Lymphoma Study

Read more

To category page