FDA approves Sagent Pharmaceuticals' two ANDAs to market granisetron

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved the Company's two abbreviated New Drug Applications (ANDAs) to market granisetron hydrochloride injection, USP (granisetron), an antiemetic used to prevent nausea and vomiting caused by chemotherapy.  Granisetron will be made available in 0.1 mg per mL and 1.0 mg per mL single-dose vials, and 4.0 mg per 4mL multi-dose vials. Sagent expects to begin marketing granisetron in the third quarter of 2010. According to 2009 IMS data, the U.S. market for granisetron approximated $26 million.

"Granisetron is an important addition to our cancer supportive care product line," said Jeffrey M. Yordon, Sagent's chief executive officer, founder and chairman of the board.  "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."

Granisetron is the fourth product approved under Sagent's 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 U.S. market.  Strides is responsible for developing and manufacturing injectable products that Sagent will market in the United States.