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-party manufacturing facility

Zealand Pharma A/S, a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced that the U.S. Food and Drug Administration has issued a Complete Response Letter for Part 1 of the New Drug Application for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with congenital hyperinsulinism for up to 3 weeks of dosing.

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