Novo Nordisk announced the submission to the Food and Drug Administration (FDA) of a New Drug Application (NDA) for faster-acting insulin aspart for the treatment of type 1 and type 2 diabetes.
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.
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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.
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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.
