�Spectrum Pharmaceuticals, Inc., (NasdaqGM: SPPI) launched FUSILEV� (levoleucovorin) for injection.
"The launch of FUSILEV establishes the foundation of Spectrum's commercial-grade oncology enfranchisement," said Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "We believe the food market potential of FUSILEV, as a successor for leucovorin, could be significant. In the U.S., there are more than 500 million milligrams of leucovorin prescribed every year. Our gross sales, under the currently sanctioned indications, ar expected to ramp up slowly until the wide range of indications and formulations are approved. We have built a squad of extremely seasoned sales and marketing professionals with a record of success in debut and marketing oncology drugs."
The Company recently filed an amendment to its pending New Drug Application (NDA) for FUSILEV Tablets. The Oncologic Drugs Advisory Committee (ODAC) has already voted affirmatively that the oral preparation is safe and in effect when victimised in the rescue of high zen methotrexate. The Company continues to work on the supplemental NDA for manipulation of the parenteral expression in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. As a answer of pre-NDA consultation, FDA has recommended a more comprehensive scope of data analysis as the footing for registration in this indication. The Company anticipates filing the supplemental NDA for colorectal cancer by the end of October 2008.
About FUSILEV (levoleucovorin) for injection
FUSILEV, a novel folate analog, is uncommitted in 50-mg vials of freeze-dried powder. It is the pharmacologically active isomer of leucovorin. FUSILEV deliver is indicated after high-dose methotrexate therapy in osteogenic sarcoma. FUSILEV is also indicated to diminish the perniciousness and weaken the personal effects of impaired methotrexate riddance and of inadvertent overdosage of folic acid antagonists. FUSILEV (levoleucovorin or (6S)-leucovorin) is the only commercially available conceptualisation comprised only of the pharmacologically active isomer of leucovorin.
Important FUSILEV (levoleucovorin) for injection Safety Considerations
FUSILEV is contraindicated for patients wHO have had previous sensitised reactions attributed to folic acid or folinic bitter. Due to calcium content, no more than 16-mL (160-mg) of levoleucovorin solution should be injected intravenously per moment. FUSILEV enhances the perniciousness of fluorouracil. Concomitant utilisation of d,l-leucovorin with
