March 23, 2010 - 1:01 AM EDT
APP Pharmaceuticals Receives Approval for Indomethacin for Injection
APP Pharmaceuticals Receives Approval for Indomethacin for Injection
Mar. 23, 2010 (Business Wire) -- APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Indomethacin for Injection. Indomethacin is therapeutically equivalent to the reference-listed drug INDOCIN® I.V., by Lundbeck, Inc.
APP will supply Indomethacin 1 mg as single dose vials. APP's Indomethacin is bar-coded, preservative-free and latex-free. According to IMS data, 2009 sales of this product in the United States were approximately $22.5 million1.
Indomethacin for Injection is used in neonates to treat patent ductus arteriosus (PDA), a common congenital heart defect. It is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 grams and 1,750 grams, and is used after 48 hours when the usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) has become ineffective.
?This approval demonstrates APP?s continuing commitment to providing products for specialized patient populations, including our country?s fragile neonates, who are among the most vulnerable of patients,? said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. ? We are pleased to add this important product to our expanding portfolio of critical care products.?
APP plans to launch Indomethacin for Injection in the second quarter of 2010.
About Fresenius Kabi Pharmaceuticals Holding, Inc. / APP Pharmaceuticals, Inc.
Fresenius Kabi Pharmaceuticals Holding, Inc., a wholly owned subsidiary of Fresenius Kabi AG, acquired APP Pharmaceuticals, Inc. on September 10, 2008. 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. 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. Fresenius SE is a global health care group with products and services for dialysis, the hospital and the medical care of patients at home. In 2009, group sales were approximately EUR 14.2 billion. For more information visit the company?s Web site at www.fresenius.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 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.
INDOCIN® I.V. is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
1 2009 IMS Data
Source: Business Wire (March 23, 2010 - 1:01 AM EDT)
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