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# FDA OKs Novo Nordisk’s Fiasp for Children
- URL: https://www.fdaweb.com/fda-oks-novo-nordisks-fiasp-for-children/
- Published: 2020-01-06T12:00:00.000Z
- Updated: 2026-09-14T15:57:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145766

FDA has approved a Novo Nordisk NDA for Fiasp (insulin aspart injection) 100 u/mL as a mealtime insulin option for children with diabetes. The company says Fiasp is the only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. It is intended to be administered at the beginning of a meal or within 20 minutes after starting a meal.

Approval is based on data from the company’s onset 7 clinical trial, a 26-week, Phase 3b, partially double-blind, basal-bolus, treat-to-target study, which investigated the efficacy and safety of Fiasp compared with conventional insulin aspart in 777 children with Type 1 diabetes. Fiasp is a man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.