APP Pharmaceuticals Receives Approval for Indomethacin for Injection
23 3월 2010 - 2:01PM
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
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