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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:  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 demonstratedNo responses were observed among the 72 patients in the Phase 2 trialInformation 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
 
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