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New Pediatric Labeling Information Database - Detail
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Pediatrics
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.
PREA(P):
P
Sponsor:
Xeris Pharmaceuticals, Inc.
NNPS:
FALSE
Therapeutic Category:
Antihypoglycemic
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