APP Pharmaceuticals Receives Approval for Sumatriptan Succinate Injection, USP

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Thu Oct 8, 2009 1:00am EDT

APP to Market Generic for Imitrex in Pre-Filled Syringes and Vials
SCHAUMBURG, Ill.--(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
Sumatriptan Succinate Injection, USP, in two dosage strengths. Sumatriptan
Succinate Injection is therapeutically equivalent to the reference-listed drug
Imitrex, which is marketed by the innovator GlaxoSmithKline. 

APP will package Sumatriptan Succinate Injection in pre-filled syringes of 4 mg
(base) /0.5 mL and 6 mg (base) / 0.5 mL. In February 2009, APP received approval
for Sumatriptan Succinate for Injection, USP packaged in single dose vials of 6
mg / 0.5 mL. 

APP's Sumatriptan Succinate Injection is AP-rated, bar-coded and latex-free.
According to IMS data, 2008 sales of this product in the United States were
approximately $241 million1. Syringe cartridges and refills accounted for more
than $218 million1. 

"The launch of this important migraine medication in pre-filled syringes
provides APP customers with a full product line of dosages and strengths for
generic Sumatriptan," said Thomas H. Silberg, president and chief executive
officer of APP Pharmaceuticals. 

Sumatriptan Succinate Injection is a vascular headache suppressant indicated for
the acute treatment of migraine attacks with or without aura and the acute
treatment of cluster headache episodes. The American Migraine Study II estimated
that as many as 28 million Americans suffer from migraine headaches. 

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.


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 Sumatriptan Succinate Injection, USP.
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. 

Imitrex is a registered trademark of GlaxoSmithKline. 

1 2008 IMS Dataview © IMS HEALTH

APP Contact
APP Pharmaceuticals, Inc.
Debra Lynn Ross
Director, Corporate Communications
847-969-8026
dross@apppharma.com
or
Investor Inquiries
Hill & Knowlton
Christine Cassiano
310-633-9495
christine.cassiano@hillandknowlton.com

Copyright Business Wire 2009

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