The US Food and Drug Administration approves Johnson & Johnson’s Doribax (doripenem for injection) as a new treatment for complicated intra-abdominal and complicated urinary tract infections, including pyelonephritis. Doribax has demonstrated activity against a wide range of Gram-positive and Gram-negative bacteria—including Pseudomonas—that cause these serious infections. Doribax belongs to a class of antibacterial agents called carbapenems, which are important for treating infections caused by Gram-positive and Gram-negative bacteria. The approval of Doribax is based on results of clinical trials in complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). In two multi-center, prospective, randomized, double-blind studies, Doribax was found to be effective and well tolerated for the treatment of complicated intra-abdominal infections.
This article was published in Drug Discovery & Development magazine: Vol. 10, No. 11, November, 2007, pp. 16.
Filed Under: Drug Discovery