Sarcoma
Spectrum Pharmaceuticals Completes the NDA Filing for ISO-Vorin
Published in Medical Letter on the CDC and FDA, July 22nd, 2007
Spectrum Pharmaceuticals, Inc., (NASDAQ:SPPI) announced that it has completed its filing with the U.S. Food and Drug Administration (FDA) with the filing of an amendment to the New Drug Application (NDA) for ISO-Vorin(TM) (levofolinic acid, or LFA) for the treatment of osteogenic sarcoma. 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 completion of this NDA continues to validate our risk-reduced...
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