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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:  12/01/2009
 
Trade Name:  Patanase
 
Generic Name or Proper Name (*):  olopatadine
 
Indications Studied:  Seasonal allergic rhinitis
 
Label Changes Summary:  * Expanded age range down to 6 years; previously approved for use in 12 years and older * Safety and effectiveness have not been established in < 6 years of age * The incidence of epistaxis (nosebleed) was higher in children 6 -11 years of age compared to the adult and adolescent population * Information on clinical trials, adverse reactions, and new one spray per nostril twice daily dosing in 6-11 years
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Alcon
 
Pediatric Exclusivity Granted Date:  08/12/2009
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine
 
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