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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:
07/30/2018
Trade Name:
Kerydin topical solution
Generic Name or Proper Name (*):
tavaborole
Indications Studied:
Topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes
Label Changes Summary:
*Safety and efficacy were established in patients 6 years of age and older. *Use in these age groups is supported by evidence from adequate and well-controlled studies of Kerydin in adults with additional data from an open-label pharmacokinetics study of tavaborole in pediatric patients 12 years to less than 17 years old. *Information on PK parameters. *Postmarketing study.
BPCA(B) and PREA(P):
B,P
Sponsor:
Anacor Pharmaceuticals, Inc.
Pediatric Exclusivity Granted Date:
07/18/2018
NNPS:
FALSE
Therapeutic Category:
Antifungal, topical
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