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news.Sagent Pharmaceuticals, a specialty pharmaceutical company, has received FDA approval for two abbreviated new drug applications (ANDAs) to market granisetron hydrochloride injection, USP (granisetron), an antiemetic used to prevent nausea and vomiting caused by chemotherapy.
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Granisetron is expected to be made available in 0.1mg per ml and 1.0mg per ml single-dose vials, and 4.0mg per 4ml multi-dose vials. Sagent expects to begin marketing granisetron in the third quarter of 2010.
Granisetron is the fourth product approved under Sagent Pharmaceuticals’ joint venture with Strides Arcolab. Under this venture, Sagent and Strides Arcolab are jointly developing, supplying and marketing more than 25 injectable products for the US market. Strides is responsible for developing and manufacturing injectable products that Sagent will market in the US.
Jeffrey Yordon, founder, chairman and CEO of Sagent Pharmaceuticals, said: “Granisetron is an important addition to our cancer supportive care product line. As with all of Sagent’s products, Granisetron features PreventIV Measures packaging and labeling in order to help healthcare workers differentiate both between the three vial sizes, as well as from other look-alike and sound-alike products.”