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Spectrum’s new Fusilev manufacturing facility wins FDA nod

Spectrum Pharmaceuticals' new manufacturing site has received FDA approval for the production of Fusilev injection for use in advanced metastatic colorectal cancer patients.

Fusilev, a folate analog, is indicated for use in combination chemotherapy with 5-fluorouracil for analgesic treatment of colorectal cancer in 2011.

With the approval of the new facility, the company now believes it can meet the Fusilev needs of entire US patient population.

Spectrum Pharmaceuticals chairman, president and chief executive officer Rajesh Shrotriya said expansion efforts carried out during 2012 expanded the companies infrastructure and capabilities.

"Adding a manufacturing site further differentiates us from single-source suppliers, which can pose supply chain risks," Shrotriya added.

"Multiple production sites help ensure long-term uninterrupted supply of FUSILEV, with our new facility allowing us to increase geographic diversification of supply."