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news.Johnson & Johnson has submitted a new drug application to the FDA for doripenem, an investigational carbapenem antibiotic for the treatment of urinary tract infections.
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Doripenem belongs to a class of antibacterial agents called carbapenems, which are useful in treating life-threatening infections caused by gram-positive and resistant gram-negative bacteria.
Pseudomonas, a gram-negative bacterium, is one of the leading causes of resistant hospital-acquired infections for which treatment options are limited. The Infectious Disease Society of America estimates that approximately 2 million people acquire bacterial infections in US hospitals each year.
Pending regulatory approval, doripenem will be marketed in the US by Ortho-McNeil. Johnson & Johnson licneses doripenem from Shionogi.