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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:  03/21/2017
 
Trade Name:  Zymar Ophthalmic Solution
 
Generic Name or Proper Name (*):  gatifloxacin
 
Indications Studied:  Bacterial conjunctivitis in pediatric patients less than 1 month of age
 
Label Changes Summary:  *Expanded the indication down to pediatric patients less than 1 year; previously approved for 1 year and older. *Information on clinical trial in pediatric patients birth to 31 days.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B
 
Sponsor:  Allergan
 
Pediatric Exclusivity Granted Date:  05/19/2009
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic, topical
 
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