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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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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
 
BPCA(B):  B
 
Sponsor:  Alcon
 
Pediatric Exclusivity Granted Date:  06/28/2006
 
NNPS:  FALSE'
 
Therapeutic Category:  Ophthalmologic hypotensive
 
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