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Company Now Markets Full Line
SCHAUMBURG, IL, USA | July 03, 2008 | APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has received final approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Granisetron Hydrochloride Injection, 1 mg/mL, 1 mL single dose, and 1mg/mL, 4mL multiple dose vials, the generic equivalent of Hoffmann-LaRoche's Kytril(R) Injection. According to IMS data, branded sales of these two dosage forms of Granisetron were approximately $72.2 million in 2007. The company currently markets Granisetron in 0.1 mg/mL, 1 mL single dose vials and will commence distributing the 1 mg/mL, 1 mL single dose, and 1mg/mL, 4 mL multiple dose vials immediately. All of APP's Granistron products are AP-rated, preservative and latex-free, and bar-coded.
Granisetron Hydrochloride Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high dose cisplatin and radiation cancer therapy. Granisetron Hydrochloride Injection is also indicated for the prevention of postoperative nausea and/or vomiting.
About APP Pharmaceuticals
APP is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on oncology, anti-infective, anesthetic/analgesic and critical care markets. The company is one of the largest producers of injectables, with more than 100 products in more than 400 dosage formulations. APP, headquartered in Schaumburg, Illinois, has offices in Canada and manufacturing operations in Illinois, New York and Puerto Rico and is traded on the Nasdaq Global Market under the symbol APPX. For more information about APP and the products it provides, please visit www.APPpharma.com.
The information contained in this news release is as of the date of this release. APP assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.
Kytril(R) Injection is a registered trademark of Hoffmann-LaRoche Inc.
SOURCE: APP Pharmaceuticals, Inc. |
