• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
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
 
-
-