Sagent Pharmaceuticals Announces FDA Approval of Midazolam Injection, USP

SCHAUMBURG, Ill., Dec. 2, 2010 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced U.S. FDA's approval of four presentations of midazolam injection, USP, a general anesthetic.  Sagent expects to launch midazolam, which will be offered in latex-free vials, in 2011.  According to 2010 IMS data, the annual U.S. market for injectable midazolam approximated $52 million.  

"Approval of midazolam marks the ninth FDA approval from our collaboration with Strides Arcolab and is an important addition to our anesthesiology portfolio," said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent.  "Each of our anesthesiology products, as well as all of our injectable products, includes Sagent's proprietary PreventIV Measures packaging and labeling designed to help with 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.  Under the collaboration, Strides is responsible for developing and supplying injectable products that Sagent will market in the United States.

About Midazolam Injection, USP

Midazolam is indicated for preoperative use (sedation, anxiolysis, amnesia), prior to or during diagnostic, therapeutic or endoscopic procedures, intravenously for induction of general anesthesia, and for continuous intravenous infusion for sedation of intubated and mechanically ventilated patients.

The package insert, which is available at www.SagentPharma.com, contains detailed information about the indication, complete side effect profile, boxed warnings 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, 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™ 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 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.

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

SOURCE Sagent Pharmaceuticals, Inc.