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Last updated on April 23, 2014 at 11:05 EDT

Sagent Pharmaceuticals Announces FDA Approval of Bacitracin for Injection, USP

May 12, 2010

SCHAUMBURG, Ill., May 12 /PRNewswire/ — Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced FDA 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. These vials will feature Sagent’s proprietary PreventIV Measures(TM) labeling and packaging, with distinctive labeling designs and easy to read drug name and dosage information. The total 2009 U.S. market for injectable bacitracin approximated $32 million, according to IMS data. Sagent expects to launch bacitracin in the third quarter of 2010.

“Sagent is well positioned to meet the needs of the growing hospital anti-infective market. Including bacitracin, our anti-infective product line now encompasses nine products,” said Jeffrey M. Yordon, Sagent’s chief executive officer, founder, and chairman of the board. “To provide pharmacies of all types with the flexibility they require to stock bacitracin appropriate to their individual needs, Sagent will offer the product in both single units and in convenient packs of ten.”

Bacitracin marks the seventh product approved from Sagent’s partnership 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 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.

Sagent’s bacitracin package insert, available at www.SagentPharma.com, contains complete prescribing information, including detailed information regarding the indication, side effect profile and boxed warning.

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, 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.

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, Inc.


Source: newswire