APP Pharmaceuticals Launches Enhanced Labeling for Heparin Sodium Injection, USP
02 Juni 2008 - 4:59PM
Business Wire
APP Pharmaceuticals, Inc. (Nasdaq:APPX) today announced the launch
of enhanced labeling for its line of Heparin Sodium Injection, USP.
The labels and cap colors for APP�s heparin have incorporated
clearly differentiating color combinations since the company began
marketing the product in 1998. Also, the current product�s labels
include bar codes at the individual unit-of-use. APP�s new labeling
represents further enhancements to help differentiate Heparin
Sodium from other heparin products, including Heparin Lock Flush
Solution, USP. As part of the company�s long-standing commitment to
patient care and in response to concerns regarding a higher risk of
medication errors associated with heparin, the new labeling will
further help healthcare professionals quickly identify the correct
drug and ultimately administer the proper dose. APP is the sole
supplier of therapeutic heparin vials to the U.S. market because
drug impurities have forced the other U.S. supplier of heparin
vials to withdraw its product from the market. APP continues to
work closely with the U.S. Food and Drug Administration (FDA) to
ensure that an uninterrupted and safe supply of heparin of the
highest quality is available for U.S. patients. According to the
Institute for Safe Medication Practices (ISMP), heparin is a
high-alert medication. These medications are defined as bearing a
heightened risk of causing significant patient harm when used in
error. ISMP encourages healthcare professionals to employ extra
safeguards to help reduce the risk of errors. �As a manufacturer of
heparin, we consider it our responsibility to help ensure the
safest possible use of our products,� said Tom Silberg, CEO, APP
Pharmaceuticals. �In bringing critical products like heparin to
market, we take a holistic approach to safety from how we source
raw materials to how we package and label the final product.�
Specifically, APP�s newly designed Heparin Sodium Injection, USP,
labels feature: Simplified upright text and increased focus on a
horizontal read of information Bolded and increased font size by
approximately 200 percent for each strength Even more vibrant cap
and label colors for each strength Notations of total unit strength
per mL and total volume Bar codes at the individual unit-of-use The
launch of enhanced labeling for heparin is another example of APP�s
proactive and independent efforts to help reduce medication errors
at the patient level: APP led the pharmaceutical industry in 2001
by being the first manufacturer to apply bar codes at the
unit-of-use level to all of its injectable products launched that
year � 2 years before the FDA�s mandate requiring manufacturers to
do so APP proactively includes TALL man lettering to the labels of
products to help healthcare professionals differentiate medications
with look-alike names APP carefully selects unique cap and label
colors for all products, as it does with heparin Wherever possible,
APP�s products are made with latex-free vial stoppers and without
preservatives Heparin is indicated for anticoagulant therapy for
patients undergoing surgery, blood transfusions, extracorporeal
circulation, dialysis procedures and other settings that require a
blood-clotting inhibitor. Product with the new labeling will begin
arriving at hospitals and dialysis centers nationwide the week of
June 2, 2008. APP supplies Heparin Sodium Injection, USP, in the
following strengths: 2,000 USP Units/2 mL (SDV); 50,000 USP
Units/10 mL (MDV); 1,000 USP Units/1 mL (MDV); 10,000 USP Units/10
mL (MDV); 30,000 USP Units/ 30 mL (MDV); 10,000 USP Units/1 mL
(MDV); 50,000 USP Units/5 mL (MDV); 20,000 USP Units/1 mL (MDV);
5,000 USP Units/1 mL (SDV). Healthcare professionals with questions
should contact APP Medical Information at 1-800-551-7176 between
the hours of 8 a.m. and 5 p.m. (CST), or e-mail
APPmedicalinfo@APPpharma.com. For Customer Service, please call
1-888-386-1300 between 7:00 a.m. and 6:00 p.m. (CST). In addition,
customers will be able to find up-to-date product information on
our website: www.APPpharma.com. About APP Pharmaceuticals, Inc. APP
is a specialty drug company that develops, manufactures and markets
injectable pharmaceutical products, focusing on oncology,
anti-infective, anesthetic/analgesic and critical care markets. The
company is one of the largest producers of injectables, with more
than 100 generic products in more than 400 dosage formulations.
APP, headquartered in Schaumburg, Illinois, has offices in Canada
and manufacturing operations in Illinois, New York and Puerto Rico
and is traded on the Nasdaq Global Market under the symbol APPX.
For more information about APP and the products it provides, please
visit www.APPpharma.com. 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 heparin. 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. These factors include, but are not
limited to, the availability and pricing of ingredients used in the
manufacture of pharmaceutical products and the ability to
successfully manufacture products in a time-sensitive and cost
effective manner. Additional relevant information concerning risks
can be found in APP Pharmaceuticals, Inc. Form 10-K for the year
ended December 31, 2007 and other documents it has filed with the
Securities and Exchange Commission. The information contained in
this news release is as of the date of this release. APP assumes no
obligations to update any forward-looking statements contained in
this press release as the result of new information or future
events or developments.
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