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新闻
FDA approves Sagent Pharmaceuticals' HEPARIN Sodium Injection, USP
July 1, 2010
SCHAUMBURG, IL. Sagent Pharmaceuticals, Inc., a privately held specialty
pharmaceutical company, today announced that the U.S. Food and Drug
Administration (FDA), has approved the Company’s nine presentations of
heparin sodium injection, USP. Heparin is a vital anticoagulant,
preventing the formation of clots and extension of existing clots within
the blood, routinely used in surgical and dialysis settings. According
to IMS, 2009 U.S. sales of all forms of un-fractionated heparin
approximated $306 million. Sagent will launch the product immediately.
“Attaining FDA approval of Sagent’s heparin vials is a major
accomplishment for our company,” said Jeffrey M. Yordon, chief executive
officer, founder, and chairman of the board of Sagent. “Amidst the many
challenges the nation’s supply of heparin has recently faced, Sagent
identified and readied a reliable source for heparin and successfully
navigated the FDA approval process for each of our heparin
presentations. We believe that our innovative approach to the packaging
and labeling of our heparin provides us with a significant advantage in
the market by better meeting the requirements of patients and customers,
positioning us for a successful launch.”
As with all of Sagent’s products, heparin is completely latex-free and
features the Company’s proprietary PreventIV Measures™ packaging and
labeling, which aids users in distinguishing between the nine
presentations. Sagent’s packaging and labeling features for heparin
include the use of a unique color for each total strength, easy to read
drug name, concentration and fill volume, and cartons printed on all
sides. PreventIV Measures™ is Sagent’s comprehensive, user-driven and
patient-centered approach to product labeling and packaging that
considers everyone handling medication along the way in order to help
prevent medication errors.
“The pace of hospital care is faster than it has ever been, requiring
increased vigilance to reduce treatment errors,” said Elaine Levy,
system director, Pharmacy Sharp HealthCare in San Diego, CA. “Sagent’s
PreventIV Measures™ approach to packaging and labeling design makes it
easier to differentiate drugs from others in the same class, even when
the medications look or sound alike. Further, it makes it easier to
distinguish between doses, which is especially important when working
with medications like heparin that have a number of concentrations and
sizes. I believe that features such as those incorporated into Sagent’s
products can help reduce those errors caused by selecting the incorrect
medication for a patient.”
About Heparin Sodium Injection, USP
Heparin is indicated for anticoagulant therapy in prophylaxis and
treatment of venous thrombosis and its extension; low-dose regimen for
prevention of postoperative deep venous thrombosis and pulmonary
embolism in patients undergoing major abdominothoracic surgery or who,
for other reasons, are at risk of developing thromboembolic disease (see
DOSAGE AND ADMINISTRATION); prophylaxis and treatment of pulmonary
embolism; atrial fibrillation with embolization; diagnosis and treatment
of acute and chronic consumptive coagulopathies (disseminated
intravascular coagulation); prevention of clotting in arterial and
cardiac surgery; and prophylaxis and treatment of peripheral arterial
embolism.
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.
Investor Contact
Ronald E. Pauli, Sagent
(847) 908-1604
Media Contact
Aline Schimmel, WCG
(312) 646-6295
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