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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:  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  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Alcon
Pediatric Exclusivity Granted Date:  06/28/2006
Therapeutic Category:  Ophthalmologic hypotensive