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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:  05/30/2017
 
Trade Name:  Zerviate Ophthalmic Solution
 
Generic Name or Proper Name (*):  cetirizine
 
Indications Studied:  Ocular itching associated with allergic conjunctivitis in patients 2 years of age and older
 
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients two years of age and older. *Use in these pediatric patients is supported by evidence from adequate and well-controlled studies in pediatric and adult patients. *New dosage form.
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Nicox Ophthalmics, Inc.
 
Pediatric Exclusivity Granted Date:  08/29/2016
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine, topical
 
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