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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
Therapeutic Category:  Antihistamine