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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Horizon Pharma Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory
 
-
-