APP Pharmaceutical Supports New USP Standards for Unfractionated Heparin
Company Implemented “Readiness” Webinar in September to Prepare Customers
October 1, 2009
SCHAUMBURG, Ill.--(BUSINESS WIRE)--Oct. 1, 2009-- APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi
Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ), and the leading supplier of heparin sodium to the U.S. market, announced today its continued support of the US Food & Drug Administration (FDA) and medical community for the October 1, 2009 implementation of the new United States Pharmacopeia (USP) monograph change for unfractionated heparin. The purpose of the USP monograph changes are to further assure the purity of the Active Pharmaceutical Ingredient (API) through specific assay tests and calibrate activity to align with the International Standard (IS) issued by the World Health Organization (WHO).
“As a proven leader in providing safe, efficacious and rigorously tested heparin products to the U.S. market, APP has always met or exceeded USP standards. From safety and quality measures in the manufacturing process, to helping prevent medical errors with cap, label and bar code enhancements, we remain committed to our promise of consistent supply and unparalleled quality,” said Thomas H. Silberg, President and Chief Executive Officer of APP Pharmaceuticals.
In order for customers to clearly differentiate product tested using the new USP standards, APP will be incorporating an “N” (for “new”) after the expiration date on every vial. An example of the vial label designation can be seen at www.APPpharma.com.
To support the medical community’s understanding and readiness for the new USP monograph change for unfractionated heparin and the introduction of new USP Reference Standards (RS), APP launched an educational webinar series with industry experts as part of its ongoing safety initiative, “Working Together for Patient Safety.”
The first webinar in the series “Readiness for New USP Standard for Unfractionated Heparin,” with Edith A. Nutescu, PharmD, Clinical Professor of Pharmacy Practice at the University Of Illinois College of Pharmacy occurred live on September 23, 2009 and is now archived for viewing through APP’s Web site (www.APPpharma.com). Participation is encouraged for anyone who administers, prescribes or manages patients taking heparin or is responsible for office or practice procedures.
“We will continue our collaborative work with the FDA to develop the best industry solutions for implementing and meeting these new USP standards and provide customers with greater confidence in the purity of their Heparin product,” said Christopher Bryant, PhD, Chief Scientific Officer of APP Pharmaceuticals. “The educational webinar series we launched in September of this year is just part of APP’s extensive efforts to bring these best practice solutions to our customers and ensure a safe supply of heparin for thousands of patients.”
Customers may also find up-to-date product information and, in the coming days, answers to questions posed during the first webinar, information regarding future webinars in the series and other pertinent information at www.APPpharma.com.
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 for fluid substitution, blood volume expansion, 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 patients all over the world. In 2008, Fresenius Kabi achieved sales of EUR 2,495 million and an operating profit of EUR 443 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. Fresenius SE is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2008, group sales were approximately EUR 12.3 billion. For more information visit the company’s Web site at www.fresenius.com.
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 heparin 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. 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 the Fresenius Kabi Pharmaceuticals Holding, Inc. 10-K for the fiscal year ending December 31, 2008 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.
Source: APP Pharmaceuticals, Inc.
Debra Lynn Ross
Director, Corporate Communications
APP Pharmaceuticals, Inc.
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