FDA to Review NDA for Faster-Acting Insulin Aspart
The NDA submission is based on results from the clinical trial program that evaluated the safety and efficacy of mealtime and after-meal faster-acting insulin aspart in approximately 2,100 adults with type 1 and type 2 diabetes.
Faster-acting insulin aspart is an investigational mealtime insulin which contains a short-acting insulin with a vitamin and an amino acid excipient for faster initial absorption rate and earlier glucose lowering effect.
Novo Nordisk intends to develop the faster-acting insulin aspart in a pre-filled delivery device FlexTouch and a 10mL vial upon approval.
For more information call (800) 727-6500 or visit Novonordisk-us.com.