• 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:  09/15/2006
Trade Name:  Noxafil Oral Suspension
Generic Name or Proper Name (*):  posaconazole
Indications Studied:  Prevention of invasive Aspergillis and Candida infections in patients 13 years of age and older
Label Changes Summary:  * Information on PK and safety studies in patients 13-17 years of age * Safety profile in patients 8-17 years of age similar to adults * Safety and effectiveness in patients below 13 years of age have not been established * Additional information on pharmacokinetics provided in patients down to 8 years of age * Studies deferred in children 0-12 years of age * New drug
Product Labeling:  Labeling  Opens a new window
Sponsor:  Schering
Therapeutic Category:  Antifungal