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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 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
Sponsor:  Lilly
Pediatric Exclusivity Granted Date:  12/03/2010
Therapeutic Category:  Antineoplastic