Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
06/17/2019
Trade Name:
Victoza
Generic Name or Proper Name (*):
liraglutide
Indications Studied:
Treatment of type 2 diabetes mellitus in pediatric patients ages 10 years and older
Label Changes Summary:
*Safety and effectiveness as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients 10 years of age and older. *Use for this indication is supported by a 26-week placebo-controlled clinical trial and a 26-week open-label extension in 134 pediatric patients 10 to 17 years with type 2 diabetes, a pediatric pharmacokinetic study, and studies in adults with type 2 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients less than 10 years of age. *The risk of hypoglycemia was higher with Victoza in pediatric patients regardless of concomitant antidiabetic therapies. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *Postmarketing study.
BPCA(B) and PREA(P):
B,P
Sponsor:
Novo Nordisk
Pediatric Exclusivity Granted Date:
05/01/2019
NNPS:
FALSE
Therapeutic Category:
Antidiabetic
-
-