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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:  09/28/2007
 
Trade Name:  Lamisil Oral Granules
 
Generic Name or Proper Name (*):  terbinafine
 
Indications Studied:  Tinea capitis
 
Label Changes Summary:  * New indication in 4 years and older * Two randomized safety and efficacy trials were conducted in patients 4 to 12 years old with tinea capitis. Terbinafine was dosed on a mg/kg basis and treated for 6 weeks * Although no hepatotoxicity was seen during trials, pre-treatment serum transaminases tests are advised. * The most common adverse events observed in the trials were nasopharyngitis, headache, pyrexia, cough, vomiting, and upper respiratory tract infection * New 125 mg and 187.5 mg oral granule formulations developed; take with food * Information on dose, PK parameters, AE profile, and instructions for use
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Novartis
 
Pediatric Exclusivity Granted Date:  12/04/2006
 
NNPS:  FALSE
 
Therapeutic Category:  Antifungal, topical
 
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