Strides Arcolab Limited (Strides) today announced that the U.S. Food and Drug Administration had granted approval of Bacitracin for injection, USP (Bacitracin), an anti-infective product used to treat pneumonia and empyema. Bacitracin will be offered in a 50,000 MU, AP-rated, preservative-free, latex-free, single-dose vial packaged both individually and in packages of ten. The total 2009 U.S. market for injectable Bacitracin approximated $32 million, according to IMS data. Launch is expected in the third quarter of 2010.
Bacitracin will be launched under the partnership between Strides and Sagent Pharmaceuticals wherein Strides is developing and supplying more than 25 injectable products for the U.S. market which will be marketed by Sagent.
About Bacitracin for injection, USP
The use of intramuscular Bacitracin is limited to the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bacitracin and other antibacterial drugs, Bacitracin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
About Strides Arcolab Limited:
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 with presence in more than 75 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.
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About Sagent Pharmaceuticals, Inc.
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.