02.06.2008 15:59:00
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APP Pharmaceuticals Launches Enhanced Labeling for Heparin Sodium Injection, USP
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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