• 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
Sponsor:  Ista Pharmaceuticals
Therapeutic Category:  Antihistamine, topical