Sagent Pharmaceuticals Announces FDA Approval of Mesna Injection
SCHAUMBURG, Ill., April 19 /PRNewswire/ — Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced the Company has received U.S. Food and Drug Administration (FDA) approval to market mesna injection (mesna), a prophylactic agent used to reduce the incidence of hemorrhagic cystitis caused by ifosfamide chemotherapy.
“Mesna is our second addition this month to our cancer supportive care product line, allowing Sagent’s sales teams to provide customers with an expanding range of products for oncology patients,” said Jeffrey M. Yordon, Sagent’s chief executive officer, founder and chairman of the board.
Mesna will be available in 1 mg per 10 mL multi-dose vials, offered in single packs and in packs of ten. According to 2009 IMS data, the U.S. market for mesna approximated $12 million. As with all Sagent products, Mesna is completely latex free and features Sagent’s proprietary PreventIV Measures(TM) packaging and labeling.
Mesna is the fifth 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 Mesna Injection
Mesna is the generic equivalent of Baxter International’s Mesnex(Ã‚®) and is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
The package insert for mesna is available at www.SagentPharma.com and contains detailed information about the indication, complete side effect profile and prescribing information.
About PreventIV Measures(TM)
PreventIV Measures(TM) 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(TM) 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