• 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:  01/10/2007
Trade Name:  Eloxatin
Generic Name or Proper Name (*):  oxaliplatin
Indications Studied:  Solid tumors
Label Changes Summary:  * The effectiveness of oxaliplatin in children has not been established * No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors * Information on clinical studies and AEs
Product Labeling:  Labeling  Opens a new window
Sponsor:  Sanofi-Aventis
Pediatric Exclusivity Granted Date:  09/27/2006
Therapeutic Category:  Antineoplastic