FDA Accepts ISO-Vorin(TM) New Drug Application Amendment Submitted by Spectrum Pharm...( - FDA Targets January ...)

- FDA Targets January 11, 2008 as Action Date

IRVINE, Calif., Sept. 13 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., (Nasdaq: SPPI) today announced that the amendment to the New Drug Application (NDA) for ISO-Vorin(TM) (levofolinic acid, or LFA) for injection has been accepted by the U.S. Food & Drug Administration (FDA). The FDA has targeted January 11, 2008 as its action date regarding the approval of the ISO-Vorin(TM) application. ISO-Vorin(TM) is the pure active isomer of calcium leucovorin. Calcium leucovorin is used after the administration of high-dose methotrexate in treating osteogenic sarcoma and is also a component of "standard of care" 5-fluorouracil (5-FU) containing regimens for the treatment of colorectal and other malignancies.

"The acceptance by the FDA of the ISO-Vorin(TM) NDA amendment represents an important milestone for Spectrum as it provides validation of our risk-reduced business model," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. "ISO-Vorin(TM) represents one of eleven promising drugs in our pipeline that have the potential to be effective therapeutic agents."

The FDA's Oncology Drug Advisory Committee had already recommended ISO-Vorin(TM) for approval, based upon clinical data demonstrating the efficacy, safety and bioequivalency in comparison to the racemic leucovorin form. During a review of the NDA application, the FDA raised questions surrounding the chemistry manufacturing and control section of the NDA. The amendment to the NDA provided manufacturing information and six months stability data on commercial batches, required by the FDA to complete its review of the ISO-Vorin(TM) NDA
'/>"/>