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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:  06/03/2010
Trade Name:  Zylet
Generic Name or Proper Name (*):  loteprednol etabonate and tobramycin
Indications Studied:  Eye lid inflammation
Label Changes Summary:  *Efficacy was not demonstrated in a study of pediatric patients 0-6 years
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B,
Pediatric Rule (R):  12/28/2010
Sponsor:  Bausch and Lomb
Pediatric Exclusivity Granted Date:  12/28/2010
Therapeutic Category:  Anti-inflammatory, Antibiotic