Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  12/17/2014
 
Trade Name:  Xtoro
 
Generic Name or Proper Name (*):  finafloxacin
 
Indications Studied:  Treatment of acute otitis externa
 
Label Changes Summary:  *New approval *The safety and efficacy of XTORO in treating acute otitis externa in pediatric patients one year or older have been demonstrated in two randomized multicenter, vehicle controlled clinical trials in total of 1234 patients aged 6 months to 85 years. *PK analyses were performed in 14 healthy adult volunteers and 36 patients ages 6 years and older with AOE. *The safety and efficacy of XTORO below one year of age have not been established
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Alcon
 
Pediatric Exclusivity Granted Date:  08/25/2014
 
Therapeutic Category:  Anti-inflammatory, topical
 
-
-