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FDA OKs APP Pharma's generic nausea injection

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July 3, 2008

SCHAUMBURG, Ill.—APP Pharmaceuticals Inc. said Thursday it received final approval from the Food and Drug Administration to market its granisetron hydrochloride injection, the generic version of Hoffmann-LaRoche's Kytril injection for chemo-induced nausea.

The injection also is able to be prescribed for prevention of postoperative nausea and/or vomiting. The drug will be available in 1 mg/mL, 1 mL single dose, and 1mg/mL, 4mL multiple dose vials.

According to IMS data, branded sales of these two doses totaled about $72.2 million in 2007.

APP Pharma currently markets granisetron in 0.1 mg/mL, 1 mL single dose vials, and will launch the others immediately.

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