American Pharmaceutical Partners, Inc. has received two tentative approvals from the US 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 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 paediatric 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.
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.