APP Pharmaceuticals Announces Marketing Clearance of Preservative-Free Heparin Lock Flush Solution, USP
Only Preservative-Free Heparin Flush in a Single Dose Vial
July 6, 2010
SCHAUMBURG, Ill., Jul 06, 2010 (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 http://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 http://www.fresenius-kabi.com. Fresenius Kabi AG is a 100% subsidiary of Fresenius SE.
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.
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
SOURCE: APP Pharmaceuticals, Inc.
Investor and Media Inquiries
APP Pharmaceuticals, Inc.
Debra Lynn Ross, ABC
Director, Corporate Communications