Mylan NV, a global pharmaceutical company, announced the US launch of levoleucovorin calcium injection 10 mg (base)/ml; 175 mg (base)/17.5 ml and 250 mg (base)/25 ml single-use vials, which is the generic version of Spectrum Pharmaceuticals' Fusilev for injection.
Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for rescue use after high-dose methotrexate therapy in osteosarcoma. Levoleucovorin is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
Levoleucovorin calcium injection 10 mg (base)/ml; 175 mg (base)/17.5 ml and 250 mg (base)/25 ml single-use vials had US sales of approximately $200 million for the 12 months ending June 30, 2015, according to IMS Health.
Currently, Mylan has 259 ANDAs pending FDA approval representing $98.5 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.