APP Pharmaceuticals Receives Approval for Sumatriptan Succinate Injection, USP
APP to Market Generic for Imitrex® in Pre-Filled Syringes and Vials
October 8, 2009
SCHAUMBURG, Ill.--(BUSINESS WIRE)--Oct. 8, 2009-- 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.
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
Source: APP Pharmaceuticals, Inc.
APP Pharmaceuticals, Inc.
Debra Lynn Ross
Director, Corporate Communications
Hill & Knowlton