FDA Approves First Generic Formulation for Azactam

Yael Waknine

June 24, 2010

June 23, 2010 — The US Food and Drug Administration (FDA) has approved the first generic formulation of aztreonam injection (APP Pharmaceuticals, Inc, a subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc; brand name, Azactam; Bristol-Myers Squibb).

Generic aztreonam injection will be launched immediately in 1-g (20 mL) and 2-g (30 mL) single-dose vial presentations and is expected to help combat shortages of the brand-name product.

"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, in a company news release. "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." 

Aztreonam injection is indicated for the treatment of infections caused by susceptible gram-negative microorganisms, including urinary tract infections, lower respiratory tract infections, septicemia, skin and skin-structure infections, intra-abdominal infections, and gynecologic infections. It also may be used as adjunctive therapy to surgery for the management of certain infections.

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