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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:  09/08/2009
 
Trade Name:  Bepreve Ophthalmic Solution
 
Generic Name or Proper Name (*):  bepotastine besilate
 
Indications Studied:  Ocular itching associated with allergic conjunctivitis
 
Label Changes Summary:  * Efficacy in pediatric patients 2 years to < 10 years based on clinical trials conducted in pediatric patients > 10 years and from adults * Safety and efficacy have not been established in pediatric patients < 2 years * New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Ista Pharmaceuticals
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine, topical
 
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