APP Pharmaceuticals Receives Final Approvals For Additional Dosages Of Granisetron Hydrochloride Injection, USP

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 07 Jul 2008 - 0:00 PDT

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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® 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 http://www.APPpharma.com. Forward-Looking Statement

The statements contained in this news release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this news release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the demand, supply and distribution of granisetron. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, but are not limited to, the availability and pricing of ingredients used in the manufacture of pharmaceutical products and the ability to successfully manufacture products in a time-sensitive and cost effective manner. Additional relevant information concerning risks can be found in APP Pharmaceuticals Form 10-K for the year ended December 31, 2007 and other documents it has filed with the Securities and Exchange Commission.
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® Injection is a registered trademark of Hoffmann-LaRoche Inc.