APP Pharmaceuticals Receives Approval For Sumatriptan Succinate Injection, USP

Main Category: Headache / Migraine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 09 Oct 2009 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

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 http://www.APPpharma.com.

Source
Fresenius Kabi AG