Doribax (doripenem injection), a 500-mg IV infusion for treating complicated UTIs (cUTI), including pyelonephritis, as well as intra-abdominal infections (cIAI), has received marketing clearance. In several multicenter, multinational trials, doripenem was shown to have a cure rate comparable to levofloxacin for cUTI and meropenem for cIAI.
Doribax was effective against a wide range of Gram-positive and Gram-negative bacteria that cause these infections, including Escherichia coli, Bacteroides fragilis, viridans group streptococci, Proteus species, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
“This is a significant new drug in the treatment of hospitalized patients with serious bacterial infections,” said Janet Woodcock, MD, FDA’s deputy commissioner for scientific and medical programs, and chief medical officer and acting director of the Center for Drug Evaluation and Research. Doribax will be manufactured by Johnson & Johnson and marketed to U.S. hospitals and other health-care institutions by Ortho-McNeil, Inc.