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# Complete Response Letter for Zealand Infant Drug
- URL: https://www.fdaweb.com/complete-response-letter-for-zealand-infant-drug/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:19:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156012

FDA has issued a complete response letter for Zealand Pharma’s dasiglucagon, intended to prevent and treat low blood sugar in children with congenital hyperinsulinism. The Danish drug company [says](https://www.globenewswire.com/news-release/2023/12/23/2800891/0/en/U-S-Food-and-Drug-Administration-issues-Complete-Response-Letter-for-dasiglucagon-in-congenital-hyperinsulinism-for-up-to-three-weeks-of-dosing-due-to-inspection-findings-at-third-.html?ref=fdaweb.com) FDA found deficiencies at the firm’s third-party manufacturing facility that are not specific to dasiglucagon. There were no concerns about the clinical data package or the drug’s safety, it says.

Zealand says it is committed to working with FDA and the manufacturer to resolve the issues. It says it expects to resubmit the NDA in the first half of this year, contingent on a successful reinspection at the third-party manufacturing firm.

Dasiglucagon is described as a glucagon receptor agonist that works by causing the liver to release stored sugar to the blood and is being evaluated to prevent and treat hypoglycemia in infants and children with congenital hyperinsulinism. Dasiglucagon is designed to be administered by continuous subcutaneous infusion using a wearable pump system. FDA granted it priority review on 8/30/2023 for up to three weeks of dosing.