Tuesday, April 29, 2008

Spectrum receives US FDA approval for Levoleucovorin for injection

Spectrum Pharmaceuticals, Inc. has received marketing approval from the US 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.

The whole story can be read here

No comments: