23 December 2023 - The complete response letter is related to deficiencies identified at a third-party manufacturing facility following an inspection but are not specific to dasiglucagon.
Zealand Pharma today announced that the US FDA has issued a complete response letter for Part 1 of the new drug application for dasiglucagon for the prevention and treatment of hypoglycaemia in paediatric patients 7 days of age and older with congenital hyperinsulinism for up to 3 weeks of dosing.