FDA approves APP's preservative-free Methotrexate Injection

Feb 22 2012

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market preservative-free Methotrexate Injection, USP. APP currently manufactures Methotrexate Injection with preservative. According to 2011 IMS data, last year there were approximately 1.8 million units sold in the United States of both formulations.

Due to the nationwide shortage of preservative-free Methotrexate, APP worked collaboratively with the U.S. Food and Drug Administration to expedite approval of this critically needed oncology drug. Once APP received notification of the approval, the Company immediately began the process of quickly scheduling production so that APP can ship to customers within the next four to six weeks.

"APP is acutely aware of the pressure that oncologists are under when a critically needed cancer treatment is unavailable," said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. "By working collaboratively with the FDA, we have helped address several industry-wide shortages of critical generic sterile injectable chemotherapeutic agents. During the past year, a number of oncology drug suppliers have reduced output due to manufacturing issues causing significant disruption to availability. I am delighted that in many cases APP Pharmaceuticals has helped to minimize shortages by significantly increasing our production. This ability to respond rapidly is one of the key strengths of our U.S.-based manufacturing platform."