Zealand Pharma provides US regulatory update on dasiglucagon in congenital hyperinsulinism

Zealand Pharma

9 October 2024 - The re-inspection of the facility was completed in August/September 2024 for which a new inspection classification is pending.

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.

Read Zealand Pharma press release


Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Dossier