Hikma launches Levoleucovorin for Injection in the US

Product is therapeutically equivalent to Spectrus Pharmaceuticals' reference listed drug Fusilev Injection.

Levoleucovorin for Injection is therapeutically equivalent to the reference listed drug Fusilev Injection, 50 mg/vial of Spectrum Pharmaceuticals

Levoleucovorin for Injection is a folate analog indicated for rescue after high dose methotrexate therapy in osteosarcoma and for diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. According to IMS Health, total US combined sales of Levoleucovorin were approximately $116 million for the 12 months ending June 2016.

Said Darwazah, Chairman and CEO of Hikma, said: “We are very pleased to be launching Levoleucovorin in the US market. This launch demonstrates our strong regulatory capabilities and the successful execution of our strategy to develop a more differentiated injectable product portfolio. We continue to work closely with the FDA leveraging our R&D, regulatory and high-quality manufacturing facilities, prioritising the re-introduction of Bedford products for patients in need.”