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news.Generic drug manufacturer Mylan Laboratories has received tentative approval from the FDA for its abbreviated new drug application for ondansetron orally disintegrating tablets.
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Ondansetron orally disintegrating tablets are the generic version of GlaxoSmithKline's Zofran tablets, which had US sales of approximately $314 million for the same strengths for the 12-month period ending December 31, 2006, according to IMS Health.
Zofran is designed to treat nausea and vomiting in as a result of chemotherapy or surgery. The tentative approval covers the drug in 4mg and 8mg strengths.