Spectrum completes NDA filing 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.

The FDA approved the new drug application (NDA) for Levoleucovorin for Injection on March 7, 2008. The amendment to the NDA filed provides manufacturing information and six months stability data on commercial batches, required by the FDA to complete its review of Levoleucovorin tablets.

Levoleucovorin is a novel folate analog formulation and the pharmacologically active isomer of calcium leucovorin. Levoleucovorin for Injection is reportedly the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (Levoleucovorin or (6S)-leucovorin).

Rajesh Shrotriya, chairman, president and CEO of Spectrum, said: “Levoleucovorin tablets is the natural product line expansion for our recently FDA approved Levoleucovorin for Injection. If approved, the tablets will provide physicians with a new, more convenient treatment option. Furthermore, we continue to work on filing the supplemental NDA with the FDA for Levoleucovorin for Injection’s use in colorectal cancer with 5-fluorouracil containing regimens.”