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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
09/28/2006
Trade Name:
Betaxon ophthalmic suspension
Generic Name or Proper Name (*):
levobetaxolol
Indications Studied:
Elevated intraocular pressure
Label Changes Summary:
Extended indication from adults to pediatric patients The adverse event profile was comparable to that seen in adults and elderly patients
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Alcon
Pediatric Exclusivity Granted Date:
06/28/2006
NNPS:
FALSE'
Therapeutic Category:
Ophthalmologic hypotensive
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