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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
Sponsor:  Allergan
Pediatric Exclusivity Granted Date:  10/10/2001
Therapeutic Category:  Ophthalmologic hypotensive