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 Aztreonam for Injection, USP in two dosage strengths. Aztreonam is therapeutically equivalent to the reference-listed drug Azactam®, which is marketed by Bristol-Myers Squibb.
“Management's Discussion and Analysis of Financial Condition and Results of Operations”
APP will launch Aztreonam immediately in single dose vials of 1 gram, 20 mL and 2 gram, 30 mL. APP's Aztreonam is AP-rated, bar-coded and latex-free. According to IMS data, 2009 sales of the branded product in the United States were approximately $86 million. The approval of Aztreonam further expands APP's leading anti-infective product line.
"The approval of APP's Aztreonam marks the first generic entrant into the market and provides clinicians with an alternative to the branded drug," said John Ducker, president and chief executive officer of APP Pharmaceuticals. "APP's entry into the market also provides hospitals with an additional source of supply for this anti-infective medication, which continues to be listed on the FDA and the American Society of Health-System Pharmacists (ASHP) drug shortage lists since the summer of 2009."
APP Pharmaceuticals, Inc.