Approval of generic glucagon for management of hypoglycemia
Prepared by: Kristal Matlock, Preneet Cheema Brar, Molly Regelmann
UpToDate as of: 1/20/2021
On December 28, 2020, the U.S. Food and Drug Administration (FDA) announced approval of the first generic Glucagon for Injection Emergency Kit, 1 mg/vial. Indications include treatment of severe hypoglycemia and as a diagnostic aid for evaluating intestinal motility. This product is synthetic human glucagon, recombinant DNA, and is bioequivalent and therapeutically equivalent to brand-name glucagon products for injection kits and the recently launched nasal (Baqsimi) and premixed (Gvoke) glucagon products. The product should become available in the first quarter of 2021. This marks a milestone for providing bioequivalent medications at a lower cost to patients and families who rely on glucagon as life-saving therapy for severe hypoglycemia.