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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:  06/12/2007
 
Trade Name:  Extina Foam, 2%
 
Generic Name or Proper Name (*):  ketoconazole
 
Indications Studied:  Topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older
 
Label Changes Summary:  * Effectiveness and safety were established in a clinical study that included 44 patients from 12-17 years of age * Studies waived in children 0-12 years of age * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Stiefel Laboratories
 
NNPS:  FALSE
 
Therapeutic Category:  Antifungal, topical
 
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