Abraxis Pharmaceutical Products (APP), the hospital-based business of Abraxis BioScience, Inc. announced that it has received tentative approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for granisetron hydrochloride injection, 1 mg/mL, 1 mL vials, USP, the generic equivalent of Hoffmann-La Roche's Kytril injection.
According to IMS, sales of granisetron hydrochloride injection for 2006 in the United States exceeded $43 million. APP expects to receive final approval for, and commence marketing of, granisetron hydrochloride injection upon patent expiration in December 2007. The product is AP-rated, preservative and latex-free, as well as bar-coded.
Granisetron Hydrochloride Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of chemotherapy including high-dose cisplatin and radiation therapy for the treatment of cancer. Granisetron Hydrochloride Injection is also indicated for the prevention of postoperative nausea and vomiting.
APP is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on hospital-based anti-infective, critical care, oncology and anesthetic/analgesic markets. With products totaling over 400 dosage forms and a market-leading pipeline, APP offers patients and healthcare providers one of the broadest portfolios of injectable products in the United States.