APP Pharmaceuticals Announces Marketing Clearance of Preservative-Free Heparin Lock Flush Solution, USP
July 06 2010 - 1:01AM
Business Wire
APP Pharmaceuticals, Inc., a wholly owned subsidiary of
Fresenius Kabi Pharmaceuticals Holding, Inc. (NASDAQ:APCVZ),
announced today that it has received clearance from the U.S. Food
and Drug Administration (FDA) to market preservative-free Heparin
Lock Flush Solution, USP in two dosage strengths, 10 USP Units/1 mL
and 100 USP Units/1 mL, and will soon launch these single dose vial
presentations.
APP is a consistent supplier of heparin to the marketplace and
this approval provides healthcare professionals with the only
preservative-free Heparin Lock Flush Solution in a single dose
vial. Benzyl alcohol, a preservative that is currently used in
multiple-dose vial preparations of Heparin Lock Flush Solution, has
been associated with toxicity in neonates and has been reported to
be associated with a fetal “Gasping Syndrome” in premature
infants1. The FDA, in concurrence with the American Academy of
Pediatrics and the Centers for Disease Control and Prevention,
recommends that clinicians do not use intravascular flush solutions
containing benzyl alcohol for newborns2. None of APP’s current
Heparin Lock Flush Solutions contain benzyl alcohol.
“The FDA clearance to market a preservative-free Heparin Lock
Flush Solution provides healthcare professionals with a safer
alternative to maintain the patency of intravenous injection
devices used in neonates and pediatric patients,” said John Ducker,
president and chief executive officer of APP Pharmaceuticals. “This
approval further expands our comprehensive heparin product
line.”
As a proven leader in providing safe, efficacious and rigorously
tested heparin products to the U.S. market, APP Pharmaceuticals
continues to meet the supply requirements of the U.S. heparin
market. As part of the company's long-standing commitment to
patient care, APP has steadily worked in collaboration with
healthcare professionals and federal agencies to ensure that the
safest heparin products are provided to hospitals and clinicians.
APP Heparin products benefit from carefully designed packaging and
labels, which aid in preventing medical errors by helping
physicians and clinicians deliver the right dose to the right
patient.
About Heparin Lock Flush Solution, USP
Heparin Lock Flush Solution, USP is intended to maintain patency
of an indwelling venipuncture device designed for intermittent
injection or infusion therapy or blood sampling. Heparin Lock Flush
Solution may also be used following initial placement of the device
in the vein, after each injection of a medication or after
withdrawal of blood for laboratory analysis. Please refer to the
product prescribing information for Heparin Lock Flush Solution,
USP for further information regarding dosage and administration.
The solution is not to be used for anticoagulation therapy. Heparin
Lock Flush Solution, USP is a sterile, nonpyrogenic, isotonic
preparation of heparin sodium injection, USP with sodium chloride
in water for injection.
About APP Pharmaceuticals, Inc.
APP Pharmaceuticals, Inc. is a fully-integrated pharmaceutical
company that develops, manufactures and markets injectable
pharmaceutical products with a primary focus on the oncology,
anti-infective, anesthetic/analgesic and critical care markets. The
company offers one of the most comprehensive product portfolios
used in hospitals, long-term care facilities, alternate care sites
and clinics within North America and manufactures a comprehensive
range of dosage formulations. Fresenius Kabi Pharmaceuticals
Holding, Inc., a wholly owned subsidiary of Fresenius Kabi AG,
acquired APP Pharmaceuticals, Inc. on September 10, 2008. For more
information about APP Pharmaceuticals, Inc., please visit the
company’s Web site at www.APPpharma.com.
About Fresenius Kabi AG
Fresenius Kabi AG is the leader in infusion therapy and clinical
nutrition in Europe and in its most important countries of Latin
America and Asia Pacific. Fresenius Kabi’s core product range
includes infusion solutions, blood volume substitutes, I.V. drugs
and parenteral nutrition, as well as products for enteral
nutrition. Furthermore, the company provides concepts for
ambulatory health care and is focused on managing and providing
home therapies. With the philosophy “caring for life” and a
comprehensive product portfolio, the company aims at improving the
quality of life of critically and chronically ill patients all over
the world. In 2009, Fresenius Kabi achieved sales of EUR 3,086
million and an operating profit of EUR 607 million. For more
information visit the company’s Web site at www.fresenius-kabi.com.
Fresenius Kabi AG is a 100% subsidiary of Fresenius SE.
Forward-Looking Statement
The statements contained in this news release that are not
purely historical are forward-looking statements within the meaning
of Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements in this news release include statements
regarding our expectations, beliefs, hopes, goals, intentions,
initiatives or strategies, including statements regarding the
demand, supply and distribution of our products. Because these
forward-looking statements involve risks and uncertainties, there
are important factors that could cause actual results to differ
materially from those in the forward-looking statements. Additional
relevant information concerning risks are discussed under the
headings “Risk Factors” and “Management’s Discussion and Analysis
of Financial Condition and Results of Operations” in the Fresenius
Kabi Pharmaceuticals Holding, Inc. 10-K for the fiscal year ending
December 31, 2009 and other documents the company has filed with
the Securities and Exchange Commission.
The information contained in this news release is as of the date
of this release. Fresenius Kabi Pharmaceuticals Holding, Inc. does
not assume any obligation to update or revise these forward-looking
statements to conform the statement to actual results, new
information, developments or changes in the Company’s
expectations.
1 http://www.rxlist.com/lok-pak-drug.htm
2 Benzyl alcohol: Toxic agent in neonatal units. American
Academy of Pediatrics. Committee on Fetus and Newborn. Committee on
Drugs. Pediatrics Vol. 73 no. 3 September 1983
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