Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that APP Pharmaceuticals will immediately begin marketing Letrozole Tablets in the U.S., after the U.S. Food and Drug Administration granted approval to market the breast cancer treatment medication to Fresenius Kabi Oncology Limited (NSE: FKONCO) (BSE: 532545). APP Pharmaceuticals and Fresenius Kabi Oncology Limited are members of the Fresenius Kabi Group of companies. Letrozole is therapeutically equivalent to the reference-listed drug Femara®, which is currently marketed by the innovator Novartis Pharmaceuticals Corporation. APP will launch the product immediately.

APP will market Letrozole in 2.5 mg tablets. According to IMS data, sales of the branded product in the United States were approximately $619.4 million, with approximately 1,775,000 bottles of 30 tablets sold annually through June 2010.

"The approval of Letrozole further expands APP's Oncology product portfolio in this strategically significant market segment," said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. "We are delighted to be able to offer this important oral medication."

About Letrozole Tablets, USP

Letrozole Tablets, USP is an aromatase inhibitor indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Letrozole is also indicated for the extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy, and as a first and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer.

1 2010 IMS Dataview © IMS HEALTH

Source:
APP Pharmaceuticals, Inc.
Fresenius Kabi AG