New Drug Application Filing for Levoleucovorin Tablets Completed by Spectrum Pharmaceuticals, Inc.

IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI) today 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 Levoleucovorin Tablets. Levoleucovorin for Injection 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 a novel folate analog formulation and the pharmacologically active isomer of calcium leucovorin. Levoleucovorin for Injection is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (Levoleucovorin or (6S)-leucovorin).

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