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Gvoke FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on Sep 11, 2019.

FDA Approved: Yes (First approved September 10, 2019)
Brand name: Gvoke
Generic name: glucagon
Dosage form: Ready-to-Use 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) or auto-injector (Gvoke HypoPen).
  • 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 side effects include nausea, vomiting, and hypoglycemia.

Development Timeline for Gvoke

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.