SCHAUMBURG, Ill.--(BUSINESS WIRE)--APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has received final approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Granisetron Hydrochloride Injection, 1 mg/mL, 1 mL single dose, and 1mg/mL, 4mL multiple dose vials, the generic equivalent of Hoffmann-LaRoche’s Kytril® Injection. According to IMS data, branded sales of these two dosage forms of Granisetron were approximately $72.2 million in 2007. The company currently markets Granisetron in 0.1 mg/mL, 1 mL single dose vials and will commence distributing the 1 mg/mL, 1 mL single dose, and 1mg/mL, 4 mL multiple dose vials immediately. All of APP’s Granistron products are AP-rated, preservative and latex-free, and bar-coded.
