Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
BPCA(B):
B
Sponsor:
Lilly
Pediatric Exclusivity Granted Date:
12/03/2010
NNPS:
FALSE'
Therapeutic Category:
Antineoplastic
-
-