Generic Version of Fusilev Launched by Mylan
Mylan has launched a generic version of Spectrum Pharmaceuticals' levoleucovorin calcium injections.
Mylan has launched a generic version of Spectrum Pharmaceuticals’ levoleucovorin calcium injections (Fusilev).
The treatment is indicated for rescue use after high-dose methotrexate therapy in osteosarcoma. It can also be used to lower toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists, according to Mylan.
The new generic version, following the FDA’s approval of Mylan’s abbreviated new drug application (ANDA), comes in 10 mg, 175 mg, and 250 mg single-use vials.
Mylan currently has 259 ANDAs pending FDA approval. These ANDAs are valued at $98.5 billion, according to IMS Health.
US sales of the Fusilev injections brought in $200 million for the fiscal year ending on June 30, 2015, according to IMS Health.
Sandoz launched its own generic version of Fusilev in May 2015.