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Gvoke FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 2, 2021.

FDA Approved: Yes (First approved September 10, 2019)
Brand name: Gvoke
Generic name: glucagon
Dosage form: Injection
Company: Xeris Pharmaceuticals, Inc.
Treatment for: Hypoglycemia

Gvoke (glucagon injection) is a ready-to-use, room-temperature stable, liquid glucagon for the treatment of severe hypoglycemia in diabetes patients ages 2 years and older.

  • Severe hypoglycemia is a serious condition that requires emergency assistance. Gvoke can be administered quickly and easily via a prefilled syringe (Gvoke PFS), auto-injector (Gvoke HypoPen), or single dose vial and syringe kit (Gvoke Kit).
  • Gvoke is injected into the lower abdomen, outer thigh, or outer upper arm. Caregivers should call for emergency assistance immediately after administering the dose.
  • Gvoke can cause serious allergic reactions, and should not be used in patients who have had a prior hypersensitivity reaction to glucagon. Patients should seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions.
  • Common adverse reactions in adults include nausea, vomiting, injection site edema raised 1 mm or greater, and headache. Common adverse reactions in pediatric patients include nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site discomfort and reaction, and urticaria.

Development Timeline for Gvoke

DateArticle
Aug 23, 2021Approval  Xeris Pharmaceuticals Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke Kit for the Treatment of Severe Hypoglycemia
Sep 10, 2019Approval  FDA Approves Gvoke (glucagon), the First Ready-to-use Stable Liquid Glucagon for Severe Hypoglycemia
Jun  6, 2019Xeris Pharmaceuticals Receives Notification of PDUFA Date Extension for Gvoke
Mar 14, 2019Xeris Pharmaceuticals Doses First Patient in Phase 2 Trial Evaluating Its Ready-to-Use Glucagon to Address Exercise-Induced Hypoglycemia
Nov 12, 2018Xeris Pharmaceuticals Releases Additional Phase 3 Clinical Trial Data on Its Ready-to-Use Liquid Glucagon Pen
Oct 23, 2018Xeris Pharmaceuticals Announces FDA Acceptance for Review of NDA for Its Ready-to-Use Glucagon Rescue Pen
Jun 25, 2018Xeris Pharmaceuticals Announces Positive Phase 3 Clinical Trial Data on Its Investigational Ready-to-Use Glucagon Rescue Pen

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.