The American Pharmaceutical Partners, Inc. received two tentative approvals from the U.S. FDA for its Abbreviated New Drug Applications (ANDAs) for Ondansetron Injection, USP (single-dose and multiple-dose vials), GlaxoSmithKline's Zofran® Injection’s generic version.
APP expects to receive the final approval and start marketing Ondansetron upon patent expiration in late December 2006 (which includes pediatric exclusivity). 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.
Source: [APP News Release]
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