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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 patients*Difluprednate 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 surgery*A similar safety profile was observed in pediatric and adult patients
Product Labeling:    Opens a new window
Sponsor:  Alcon
Pediatric Exclusivity Granted Date:  03/21/2013
Therapeutic Category:  Anti-inflammatory, topical