FDA Approves Novo Nordisk’s Fiasp® for Children with Diabetes

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By : dLife Editors

The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk’s Fiasp® (insulin aspart injection) 100 u/mL for use as a new mealtime insulin option for children with diabetes.

Fiasp is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation.

Fiasp is now available for use in children and adults in three different dosing options: multiple daily injections (MDI), continuous subcutaneous insulin infusion pumps and intravenous infusion under supervision by a healthcare professional.

Managing diabetes can be challenging for parents and caregivers given it is hard to know exactly how much or how quickly their children will eat, making mealtime insulin dosing difficult.

“As a parent of a son living with Type 1 diabetes, I know first-hand how tough it can be to address the inevitable blood sugar spikes around mealtimes,” said Todd Hobbs, vice president, and U.S. chief medical officer of Novo Nordisk. “Children can be unpredictable and having the option of fast-acting insulin that doesn’t require pre-meal dosing like Fiasp® is a welcome development for the diabetes community.”

The approval is based on the FDA’s review of data from the onset 7 clinical trial, which confirmed the efficacy and safety of Fiasp in children.


  1. Novo Nordisk. (2019, Jan. 6). FDA approves Fiasp® for the treatment of children with diabetes. PR Newswire. Retrieved Jan. 6, 2019 from https://prnmedia.prnewswire.com/news-releases/fda-approves-fiasp-for-treatment-of-children-with-diabetes-300981601.html