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Zegalogue FDA Approval History

Last updated by Judith Stewart, BPharm on April 6, 2021.

FDA Approved: Yes (First approved March 22, 2021)
Brand name: Zegalogue
Generic name: dasiglucagon
Dosage form: Injection
Company: Zealand Pharma A/S
Treatment for: Hypoglycemia

Zegalogue (dasiglucagon) is a glucagon analog antihypoglycemic agent for the treatment of severe hypoglycemia in diabetes patients aged 6 years and older.

Development timeline for Zegalogue

Mar 22, 2021Approval FDA Approves Zegalogue (dasiglucagon) Injection for the Treatment of Severe Hypoglycemia in People with Diabetes
May 22, 2020Zealand Pharma Announces FDA acceptance of New Drug Application for the Dasiglucagon HypoPal® Rescue Pen for Treatment of Severe Hypoglycemia
Sep 24, 2019Zealand Pharma Achieves Primary and All Key Secondary Endpoints in Pediatric Phase 3 Trial with Dasiglucagon for Severe Hypoglycemia
Jul  3, 2017Zealand Initiates First Phase 3 Trial with Dasiglucagon for the Treatment of Severe Hypoglycemia in Diabetes

Further information

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