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FDA Approves Sagent's Polymyxin B for Injection, USP.

Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT), Schaumberg. Ill., has announced U.S. FDA approval of polymyxin B for injection, USP, an antibacterial drug, in 500,000 units per vial, latex-free glass vials. According to 2010 IMS data, the U.S. market for injectable polymyxin B approximated $8 million. As with all products in Sagent's portfolio, polymyxin B features the company's PreventIV Measures packaging and labeling designed to aid in the reduction of medication errors.

Sagent and Strides Arcolab are jointly developing, supplying and marketing more than 20 injectable products for the U.S. market. Polymyxin B is the eleventh product approved under the Sagent and Strides Arcolab partnership. Under the collaboration, Strides is responsible for developing and supplying injectable products that Sagent will market in the United States.

About Polymyxin B for Injection, USP

Polymyxin B sulfate is an antibacterial drug used in the treatment of infections of the urinary tract, meninges and bloodstream caused by susceptible strains of Pseudomonas aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Pseudomonas aeruginosa.

Detailed information about the indications, warnings, complete side effect profile, and full prescribing information will be available in the package insert. Please visit for more information.

About Sagent Pharmaceuticals, Inc.

Sagent Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectable products. Sagent operates a global network of resources, comprised of rapid development capabilities, sophisticated manufacturing and innovative drug-delivery technologies, which quickly yields an extensive portfolio of pharmaceutical products that fulfills the evolving needs of patients.

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 six 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.

For more information, visit or call 312/646-6298.
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Publication:Biotech Business
Date:Aug 1, 2011
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