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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:
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
BPCA(B):
B
Sponsor:
Alcon
Pediatric Exclusivity Granted Date:
03/21/2013
NNPS:
FALSE'
Therapeutic Category:
Anti-inflammatory, topical
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