BRIEF-Novo Nordisk says U.S. FDA requests more information on faster-acting insulin aspart
Oct 8 Novo Nordisk A/S
* 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.
* Says drug application for aspart was submitted to the FDA in December 2015.
* Says insulin aspart is currently also under review in the EU, Switzerland, Canada, Brazil, South Africa and Argentina. Source text for Eikon: Further company coverage: (Reporting by Jacob Gronholt-Pedersen; editing by Mark Heinrich)