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