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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:  01/22/2014
 
Trade Name:  Xerese
 
Generic Name or Proper Name (*):  acyclovir/ hydrocortisone
 
Indications Studied:  Treatment of recurrent herpes labialis
 
Label Changes Summary:  * Expanded indication to include 6 years to less than 12 years; previously approved for use in 12 years and older *Safety and effectiveness in pediatric patients less than 6 years of age have not been established *Adverse reactions similar to those observed in adults* Information on dose, and clinical trial
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Valeant International Bermuda
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral, topical
 
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