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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:  03/22/2013
 
Trade Name:  Durezol
 
Generic Name or Proper Name (*):  difluprednate
 
Indications Studied:  Treatment of post-operative inflammation following cataract surgery
 
Label Changes Summary:  Expanded the indication from adults to pediatric patientsDifluprednate compared to prednisolone acetate ophthalmic was evaluated in a 3-month, multicenter, double-masked trial in 79 pediatric patients 0 to 3 years for the treatment of inflammation following cataract surgeryA similar safety profile was observed in pediatric and adult patients
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Alcon
 
Pediatric Exclusivity Granted Date:  03/21/2013
 
NNPS:  FALSE'
 
Therapeutic Category:  Anti-inflammatory, topical
 
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