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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:
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
PREA(P):
P
Sponsor:
Bausch and Lomb
NNPS:
FALSE
Therapeutic Category:
Anti-inflammatory, topical
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