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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  09/10/2019
Trade Name:  Gvoke
Generic Name or Proper Name (*):  glucagon
Indications Studied:  Severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above
Label Changes Summary:  *Safety and effectiveness for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients ages 2 years and above. *Use for this indication is supported by evidence from a study in 31 pediatric patients ages 2 and older with type 1 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients younger than 2 years of age. *New dosage form. *Postmarketing study.
Sponsor:  Xeris Pharmaceuticals, Inc.
Therapeutic Category:  Antihypoglycemic