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Chemotherapy
Tentative FDA approval received for Ondanestron Hydrochloride
July 24th, 2005
Par Pharmaceutical Companies, Inc., (PRX) announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the company's abbreviated new drug application (ANDA) for ondansetron hydrochloride (HCl) orally disintegrating tablets (ODT) in 4 mg and 8 mg strengths. GlaxoSmithKline currently markets ondansetron HCl ODT under the brand name Zofran ODT. The product is used for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, certain radiotherapies, and the prevention of postoperative nausea and/or vomiting. Annual U.S. sales of Zofran ODT are approximately $225 million. Par's wholly owned...
Source: Medical Letter on the CDC & FDA (2005-07-24)
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