Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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.
 
PREA(P):  P
 
Sponsor:  Xeris Pharmaceuticals, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypoglycemic
 
-
-