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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:  06/08/2007
 
Trade Name:  Betoptic S
 
Generic Name or Proper Name (*):  betaxolol
 
Indications Studied:  Elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension
 
Label Changes Summary:  * Extended indication from adults to pediatric patients * The adverse reaction profile was comparable to that seen in adults
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Alcon
 
Pediatric Exclusivity Granted Date:  02/28/2007
 
NNPS:  FALSE
 
Therapeutic Category:  Ophthalmologic hypotensive
 
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