• 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:  09/28/2006
Trade Name:  Azopt ophthalmic suspension
Generic Name or Proper Name (*):  brinzolamide
Indications Studied:  Elevated intraocular pressure
Label Changes Summary:  * IOP-lowering efficacy was not demonstrated in a 3-month controlled clinical study in which brinzolamide was dosed only twice a day in pediatric patients 4 weeks to 5 years of age
Product Labeling:  Labeling  Opens a new window
Sponsor:  Alcon
Pediatric Exclusivity Granted Date:  06/28/2006
Therapeutic Category:  Ophthalmologic hypotensive