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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:  07/20/2018
 
Trade Name:  Lotemax
 
Generic Name or Proper Name (*):  loteprednol etabonate ophthalmic gel
 
Indications Studied:  Treatment of postoperative inflammation and pain following ocular surgery
 
Label Changes Summary:  *Safety and effectiveness have been established in the pediatric population. *Use in this population is supported by evidence from adequate and well-controlled trials of Lotemax in adults with additional data from a safety and efficacy trial in pediatric patients from birth to 11 years. *Information on clinical study. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bausch and Lomb
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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