FDA Approves New Drug Application (NDA) for LEVOleucovorin

FDA has approved new drug application (NDA) for LEVOleucovorin, Spectrum’s first proprietary oncology drug
proprietary drug Levoleucovorin for injection (formerly known as ISO-Vorin, a novel folate analog, is the first new oncology drug approved by the FDA in 2008.

Proprietary Brand Names Submitted by Company Currently Under Review by FDA.

LEVOleucovorin Has Been Marketed with Success in Europe and Japan by Wyeth, Sanofi and Others.
Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for Levoleucovorin for Injection. It is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. LEVOleucovorin is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (Levoleucovorin or (6S)-leucovorin). The Company currently expects its commercial launch by June 2008.
tag: FDA, Drug Approval, Spectrum Pharmaceuticals, Levoleucovorin, leucovorin, folate analog, oncology drug