SCHAUMBURG, Ill., April 14 /PRNewswire/ -- 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 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.
The package insert for granisetron is available at www.SagentPharma.com and contains detailed information about the indication, complete side effect profile and prescribing information.
About Sagent Pharmaceuticals
Sagent Pharmaceuticals, founded in 2006, is a privately held specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectable products. Sagent has created a unique, global network of resources, comprised of rapid development capabilities, sophisticated manufacturing and innovative drug-delivery technologies, quickly yielding an extensive portfolio of pharmaceutical products that fulfills the evolving needs of patients. Sagent currently has more than 200 products in development.
About Strides Arcolab, Ltd.
Strides Arcolab, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.
Additional information is available at the company's website at www.stridesarco.com.
CONTACT: Investors, Ronald E. Pauli of Sagent, +1-847-908-1604; or Media,
Aline Schimmel of WCG, +1-312-646-6295, for Sagent Pharmaceuticals, Inc.
Web site: http://www.SagentPharma.com/
http://www.stridesarco.com/
