APP Pharmaceuticals Announces Approval Of Ganciclovir For Injection, USP

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Regulatory Affairs / Drug Approvals;  HIV / AIDS;  Eye Health / Blindness
Article Date: 23 Jun 2010 - 0:00 PDT

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APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced 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.

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 million1.

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."

About Ganciclovir for Injection, USP

Ganciclovir for Injection is indicated for the treatment of CMV retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS). Ganciclovir for Injection is also indicated for the prevention of CMV disease in transplant recipients at risk for CMV disease. Safety and efficacy of ganciclovir for injection has not been established for congenital or neonatal cmv disease, nor for the treatment of established cmv disease other than retinitis, nor for use in non-immunocompromised individuals.

1 Per IMS Dataview © IMS Health as of December 31, 2009

Source:
APP Pharmaceuticals, Inc.
Fresenius Kabi AG

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