APP receives FDA marketing approval for Metoprolol Tartrate Injection

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 Metoprolol Tartrate Injection, USP, and expects to launch the medication soon.

“Additionally, this approval further expands APP's growing Critical Care product line.”

Metoprolol Tartrate Injection, USP is therapeutically equivalent to the reference-listed drug Lopressor®, which is marketed by Novartis International AG. According to IMS Health, sales of this product in the United States for 2009 were approximately $13 million.

"Heart disease is a leading cause of death in the United States and APP's approval of Metoprolol Tartrate Injection, USP, will provide an affordable, generic treatment for millions of patients who suffer a heart attack or acute myocardial infarction each year," said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. "Additionally, this approval further expands APP's growing Critical Care product line."

APP's Metoprolol Tartrate Injection, USP is AP-rated, preservative-free and bar-coded, and is packaged in single dose 5 mg/5 mL vials.