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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:  07/31/2009
 
Trade Name:  Xerese
 
Generic Name or Proper Name (*):  acyclovir/ hydrocortisone
 
Indications Studied:  Recurrent herpes labialis (cold sores) in 12 years of age and older
 
Label Changes Summary:  Use in adolescents e12 years is supported by evidence from studies in adults with additional safety data in adolescents e12 years Safety and effectiveness in pediatric patients < 12 years have not been established Information on clinical studies, and adverse events New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Medivir
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral, topical
 
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