Aztreonam for injection, USP 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 including those associated with postoperative wounds, ulcers and burns, intra-abdominal infections and gynecologic infections.
It is also indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms.
APP Pharma is expected to introduce Aztreonam immediately in single dose vials of 1gram, 20ml and 2gram, 30ml. APP Pharma claimed that its Aztreonam is AP-rated, bar-coded and latex-free. The approval of Aztreonam further expands APP’s leading anti-infective product line.
John Ducker, president and CEO of APP Pharma, said: “The approval of APP’s Aztreonam marks the first generic entrant into the market and provides clinicians with an alternative to the branded drug.
“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.”