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:
07/06/2017
Trade Name:
Vimovo
Generic Name or Proper Name (*):
naproxen/esomeprazole magnesium
Indications Studied:
Juvenile idiopathic arthritis (JIA) in adolescent patients 12 years of age and older weighing at least 38 kg
Label Changes Summary:
*Safety and effectiveness have been established in adolescent patients 12 years and older weighing at least 38 kg for the symptomatic relief of JIA and to decrease the risk of developing naproxen-associated gastric ulcers. *Use in this age group is based on extrapolation of adequate and well-controlled studies in adults and supported by a 6 month safety study including pharmacokinetic assessment of naproxen and esomeprazole magnesium in 36 adolescent patients with JIA. *The safety profile in adolescent patients with JIA was similar to adults with RA. *Safety and effectiveness in pediatric patients less than 12 years or less than 38 kg with JIA have not been established. *Information on recommended dosing, and PK. *New indication.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Horizon Pharma Inc.
NNPS:
FALSE
Therapeutic Category:
Anti-inflammatory
-
-