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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:  12/20/2001
 
Trade Name:  Alphagan
 
Generic Name or Proper Name (*):  brimonidine
 
Indications Studied:  Prevention of post-operative IOP elevations
 
Label Changes Summary:  * Safety and effectiveness established down to 2 years * Somnolence in patients 2 to 6 years (50-83%) versus patients 7 years of age or older (25%)
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Allergan
 
Pediatric Exclusivity Granted Date:  10/10/2001
 
NNPS:  FALSE
 
Therapeutic Category:  Ophthalmologic hypotensive
 
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