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news.Barr Pharmaceuticals has received tentative approval from the Food and Drug Administration for its generic version of Roche Laboratories' Kytril tablets, indicated for nausea and vomiting.
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Barr anticipates receiving final approval following the expiration of Roche's patent in December 2007, or in June 2008 if Roche seeks and is granted pediatric exclusivity.
Kytril is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin, and, nausea and vomiting associated with radiation.
The product had annual sales of approximately $90 million for the twelve months ended November 2006, based on IMS sales data. A tentative approval does not allow Barr to market the generic drug product.