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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:  01/30/2015
 
Trade Name:  Pazeo
 
Generic Name or Proper Name (*):  olopatadine hydrochloride
 
Indications Studied:  Ocular itching associated with allergic conjunctivitis
 
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients 2 years and older. Use in these pediatric patients is supported by evidence from adequate and well-controlled studies in adults and an adequate and well controlled study evaluating the safety in pediatric and adult patients *New formulation
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Alcon
 
Therapeutic Category:  Antihistamine, topical
 
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