APP receives FDA approval to market Gemcitabine HCI for Injection, USP in 2 g dosage

May 19 2011

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 Gemcitabine HCI for Injection, USP, in the 2 g dosage strength. APP will launch this presentation of Gemcitabine immediately.

In January 2011, Teva Pharmaceuticals USA, Inc. received approval and APP Pharmaceuticals launched Gemcitabine HCI for Injection in the 200 mg and 1g dosage forms as part of a commercialization, manufacture and supply agreement with Teva.

According to IMS Health data, 2010 branded product sales of all dosage strengths of Gemcitabine HCI for Injection in the United States were approximately $780 million. Sales of the generic 2 g dosage strength accounted for $33.3 million, with 36,000 units sold from November 2010 thru March 2011.

"With the approval of the 2 g dosage, APP becomes the only generic manufacturer to offer its customers all three dosage strengths of this critically important oncology drug," said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. "This approval further strengthens our leading oncology portfolio."