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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:  07/24/2019
 
Trade Name:  Baqsimi nasal powder
 
Generic Name or Proper Name (*):  glucagon
 
Indications Studied:  Treatment of severe hypoglycemia in patients with diabetes ages 4 years and older
 
Label Changes Summary:  *Safety and effectiveness for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients ages 4 years and above. Use for this indication is supported by evidence from a study in 48 pediatric patients from 4 to <17 years of age with type 1 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients younger than 4 years. *Information on dosing and administration, adverse reactions, clinical trials, and pharmacokinetics and pharmacodynamics. *New dosage form.
 
PREA(P):  P
 
Sponsor:  Eli Lilly
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypoglycemic
 
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