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news.APP Pharmaceuticals has received final approvals from the FDA of its abbreviated new drug applications for Granisetron hydrochloride injection, 1mg/ml, 1ml single dose, and 1mg/ml, 4ml multiple dose vials, the generic equivalent of Hoffmann-LaRoche's Kytril injection.
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The company currently markets Granisetron in 0.1mg/ml, 1ml single dose vials and will commence distributing the 1mg/ml, 1ml single dose, and 1mg/ml, 4ml multiple dose vials immediately. All of APP’s Granistron products are said to be AP-rated, preservative and latex-free, and bar-coded.
Granisetron hydrochloride injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high dose cisplatin and radiation cancer therapy.