• 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:  03/17/2011
 
Trade Name:  Alimta
 
Generic Name or Proper Name (*):  pemetrexed disodium
 
Indications Studied:  Refractory and recurrent solid tumors, including osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, and neuroblastoma
 
Label Changes Summary:  * Efficacy in pediatric patients has not been demonstrated* No responses were observed among the 72 patients in the Phase 2 trial* Information on dosing, clinical trial, adverse events and pharmacokinetics
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Lilly
 
Pediatric Exclusivity Granted Date:  12/03/2010
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
-
-