American Pharmaceutical gets tentative FDA approval for anti-nausea drug

By Elaine Rigoli

Tampa, Fla., March 9 - American Pharmaceutical Partners, Inc. announced Thursday that it has received two tentative approvals from the Food and Drug Administration for its abbreviated New Drug Applications for ondansetron injection, USP, single-dose and multiple-dose vials, the generic equivalent of GlaxoSmithKline's Zofran injection.

Sales in 2005 of ondansetron in the United States exceeded $587 million, according to a news release.

American Pharmaceutical said it expects to receive final approval and start marketing ondansetron upon patent expiration in late December 2006, which includes pediatric exclusivity.

The company said it 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, the release said.

Schaumburg, Ill.-based American Pharmaceutical is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical-care markets.

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