New Pemetrexed Formulation to Be Reviewed by FDA
Eagle announced the submission of the New Drug Application (NDA) for a new pemetrexed drug product to the Food and Drug Administration (FDA).
The NDA proposes the use of ready-to-dilute pemetrexed injection for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) and mesothelioma (in combination with cisplatin).
Pemetrexed, an antifolate, exerts is action by disrupting folate-dependent metabolic processes essential for cell replication. In vitro studies have shown that pemetrexed inhibits thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase, which are folate-dependent enzymes involved de novo biosynthesis of thymidine and purine nucleotides. Its polyglutamated metabolites are thought to have an increased intracellular half-life resulting in prolonged drug action in malignant cells.
Eagle's ready-to-dilute pemetrexed injection is designed to be supplied as a 500mg strength liquid in multi-dose vials and is intended for IV infusion.
For more information call (855) 318-2170 or visit EagleUS.com.