APP Pharmaceuticals receives FDA approval to market Ganciclovir for Injection, USP

Jun 22 2010

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Ganciclovir for Injection, USP. Ganciclovir for Injection, USP is therapeutically equivalent to the reference-listed drug Cytovene ^®-IV, which is marketed by Roche Laboratories, Inc.

“This approval reinforces APP's commitment to provide our customers, and the patients they treat, with a consistently expanding portfolio of products”

APP will soon launch Ganciclovir for Injection and will package the product in single dose, 500 mg vials. APP's Ganciclovir for Injection is AP-rated, latex-free and bar-coded. According to IMS Health, sales of this product for 2009 in the United States were approximately $13.5 million.

Ganciclovir for Injection is an antiviral drug, which is used in the treatment of Cytomegalovirus (CMV) retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS), as well as for the prevention of CMV disease in transplant recipients at risk for CMV disease. CMV disease is a serious illness that can lead to blindness, transplant graft loss and potential loss of life.

"This approval reinforces APP's commitment to provide our customers, and the patients they treat, with a consistently expanding portfolio of products," said John Ducker, president and chief executive officer of APP Pharmaceuticals. "The addition of Ganciclovir for Injection further strengthens APP's broad anti-infective portfolio and market leadership position."