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FDA Approves Sagent Pharmaceuticals’ Heparin Sodium Injection, USP

July 1, 2010 By Bio-Medicine.Org

SCHAUMBURG, Ill., July 1 /PRNewswire/ — 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
unfractionated heparin approximated $306
million
.  Sagent will launch the product
immediately.

(Photo:  http://photos.prnewswire.com/prnh/20100701/SF29279)

(Photo:  http://www.newscom.com/cgi-bin/prnh/20100701/SF29279)

“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 com

‘/>”/>

SOURCE

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