Spectrum Pharmaceutecals Inc (SPPI)

[primarywatcher]

NOT Fusilev sNDA - but FDA Approval of FUSILEV®’s Ready-to-Use Formulation (RTU)
http://finance.yahoo.com/news/Spectrum-Pharmaceuticals-bw-350132648.html?x=0&.v=1

* Until Now FUSILEV® Has Been Available Only As A Lyophilized Product

* FUSILEV® sNDA For Use In Advanced Metastatic Colorectal Cancer is Currently Under Review By The FDA
o PDUFA Action Date – April 29, 2011

* FUSILEV® Is Currently FDA Approved and Marketed by Spectrum For:
o Rescue After High-Dose Methotrexate Therapy in
Osteosarcoma;
o To Diminish the Toxicity and Counteract the Effects of Impaired Methotrexate Elimination, and of Inadvertent Overdosage of Folic Acid Antagonists