Company Now Markets Full Line
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 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.
Investors and Media Inquiries:
APP Pharmaceuticals, Inc.
Maili
Bergman, Director, Investor Relations, 310-405-7522
or
PondelWilkinson
Inc.
Robert Jaffe, 310-279-5969
