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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:  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  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Novartis
Pediatric Exclusivity Granted Date:  09/21/2009
Therapeutic Category:  Antiviral