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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
Sponsor:  Medivir
Therapeutic Category:  Antiviral, topical