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news.The FDA has granted final approval for Teva Pharmaceutical Industries's abbreviated new drug applications to market its generic version of Roche's antinauseant and antiemetic agent Kytril, granisetron hydrochloride, injection, 1mg (base)/mL in 1mL single-dose vials and 1mg (base) tablets.
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The company said that shipment of these products has commenced.
As the first company to file an abbreviated new drug application (ANDA) with a Paragraph IV patent certification for granisetron hydrochloride injection, 1mg (base)/mL in 1mL single-dose vials, Teva said that it has been awarded 180 days marketing exclusivity for this product.