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Treats severe hypoglycemia. NDA 212097, held by Xeris. Glucagon.
As of Nov 13, 2026, NDA 212097 (Gvoke Pfs, Gvoke Hypopen, Gvoke Kit), held by Xeris, was first approved by FDA on Sep 10, 2019, with 5 approved supplements and 0 published complete response letters.
First approved: Sep 10, 2019
Review: Standard
Supplements approved: 5
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients 1.1 Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
