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Sagent Pharmaceuticals Announces FDA Approval of Midazolam Injection, USP

Thu, 12/02/2010 - 7:34am
Bio-Medicine.Org

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 desi

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