Posted by Michael Wonder on 26 Dec 2023
US 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
23 December 2023 - The CRL 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 pplication 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.
