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news.The FDA has granted tentative approval to Teva Pharmaceutical's application to market a generic version of Roche AG's injectable drug Kytril, an anti-nausea and vomiting agent.
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Final approval of Teva’s drug is anticipated subsequent to the expiry of patent protection in December 2007.
Teva’s generic version of the drug is called Granisetron HCl Injection, and it will be available in 1mg/ml single dose vials, and 4mg/4ml in multi-dose vials.
Kytril is designed to suppress the side effects of nausea and vomiting associated with chemotherapy. During chemotherapy, the damaging of healthy cells can cause a chain reaction where the body tries to purge the disruptive elements of chemotherapy through vomiting.
According to Teva, total annual US sales of the brand product, in both configurations, are approximately $140 million for all indications.