SCHAUMBURG, Ill., March 9 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. , today announced that it has received two tentative approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Ondansetron Injection, USP, single-dose and multiple-dose vials, the generic equivalent of GlaxoSmithKline's Zofran(R) Injection. According to IMS, sales in 2005 of ondansetron in the United States exceeded $587 million. APP expects to receive final approval and commence marketing ondansetron upon patent expiration in late December 2006 (which includes pediatric exclusivity). APP will sell ondansetron in AP rated single-dose and multiple-dose bar coded, latex-free vials.
Ondansetron Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin, and prevention of postoperative nausea and/or vomiting.
About American Pharmaceutical Partners, Inc.
American Pharmaceutical Partners, Inc. is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets. Abraxis(TM) Oncology, the proprietary division of APP, is devoted entirely to developing and promoting innovative, next-generation cancer therapies such as ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). For more information, visit APP's website at www.appdrugs.com and www.abraxisoncology.com.
Because these forward-looking statements, whether expressed or implied, 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, without limitation, successfully commercializing ondansetron, the difficulty in predicting the timing or outcome of other product research and development efforts, potential product characteristics and indications, marketing approvals and launches of other products, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in our Form 10-K for the year ended December 31, 2004 and other documents filed by us with the Securities and Exchange Commission.
Zofran(R) is a registered trademark of GlaxoSmithKline.
Contacts: American Pharmaceutical Partners, Inc.
Director, Corporate Communications
American Pharmaceutical Partners, Inc.