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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:  02/06/2013
Trade Name:  Zylet
Generic Name or Proper Name (*):  loteprednol etabonate and tobramycin
Indications Studied:  Treatment of blepharoconjunctivitis
Label Changes Summary:  "" Efficacy was not demonstrated in a study of pediatric patients 0-6 years"
Product Labeling:  Labeling  Opens a new window
Sponsor:  Bausch and Lomb
Pediatric Exclusivity Granted Date:  12/28/2010
Therapeutic Category:  Antibiotic, topical