US FDA has approved Abbreviated New Drug Applications (ANDAs) for Granisetron hydrochloride injection of APP Pharmaceuticals, Inc.
APP Pharmaceuticals, Inc., a leading manufacturer of multi-source and branded injectable pharmaceutical products, has received final approvals from the US 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.
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. Granisetron hydrochloride injection is also indicated for the prevention of postoperative nausea and/or vomiting.