APP Pharmaceuticals, a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals, has received FDA approval to market preservative-free Methotrexate Injection, USP.
APP worked with the FDA to expedite approval of the oncology drug due to nationwide shortage, the company said. The company began the process of scheduling production so that it can ship to customers within the next four to six weeks. APP currently manufactures Methotrexate Injection with preservative.
APP Pharmaceuticals president and CEO John Ducker said APP is acutely aware of the pressure that oncologists are under when a critically needed cancer treatment is unavailable. “The ability to respond rapidly is one of the key strengths of our US-based manufacturing platform,”Ducker added.