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:  09/08/2009
 
Trade Name:  Bepreve Ophthalmic Solution
 
Generic Name or Proper Name (*):  bepotastine besilate
 
Indications Studied:  Ocular itching associated with allergic conjunctivitis
 
Label Changes Summary:  Efficacy in pediatric patients 2 years to < 10 years based on clinical trials conducted in pediatric patients > 10 years and from adults Safety and efficacy have not been established in pediatric patients < 2 years New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Ista Pharmaceuticals
 
NNPS:  FALSE'
 
Therapeutic Category:  Antihistamine, topical
 
-
-