Novo Nordisk degludec applications hit with 3-month delay
This article was originally published in Scrip
Executive Summary
The US FDA has extended by three months its review of the new drug applications (NDAs) for Novo Nordisk's experimental ultra-long-acting insulins degludec and insulin degludec/insulin aspart as treatments for Type I and Type II diabetes, with regulators seeking further data clarification and analyses, the Danish firm said in a 8 June statement.