Sagent Pharmaceuticals Announces FDA Approval of Granisetron Hydrochloride Injection, USP

Thursday, April 15, 2010 Drug News
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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 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.

About Granisetron Hydrochloride Injection, USP

Granisetron is the generic equivalent of Kytril® from F. Hoffmann-La Roche AG.  Granisetron is indicated for the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.

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 PreventIV Measures™

PreventIV Measures is Sagent's comprehensive, user-driven and patient-centered approach to product labeling and packaging that is designed to help prevent medication errors. It incorporates unique label and carton designs, cap and label colors, bar coding and other features that are designed to make it easier to differentiate drugs and identify the correct dose.

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.

To Discover Injectables Excellence™ and learn more about Sagent, please visit www.SagentPharma.com.  

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.

The company has 14 manufacturing facilities across 6 countries, including its joint venture with Aspen in India and has a marketing presence in more than 60 countries in developed and emerging markets. Manufacturing is ably supported by a 350-scientist strong global R&D Centre located in Bangalore.

Additional information is available at the company's website at www.stridesarco.com.

SOURCE Sagent Pharmaceuticals, Inc.



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