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New Pediatric Labeling Information Database - Detail
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Pediatrics
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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