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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:
12/24/2009
Trade Name:
Famvir
Generic Name or Proper Name (*):
famciclovir
Indications Studied:
Treatment of children 1 month 12 years of age w/ herpes simplex (HSV) & 1 12 years w/ varicella zoster (VSV)
Label Changes Summary:
Available data are insufficient to support the use of famciclovir for the treatment of children with chickenpox or infections due to HSV The PK profile and safety were studied in 2 open-label studies: (1) a single-dose PK and safety study in infants 1 month to <1 year of age who had an active herpes simplex virus (HSV) infection or who were at risk for HSV infection and (2) a single-dose PK, multiple-dose safety study in children 1 to <12 years of age with clinically suspected HSV or varicella zoster virus (VZV) infection Information added to Pediatric Use
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Novartis
Pediatric Exclusivity Granted Date:
09/21/2009
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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