Pharmaceutical Business review

J&J submits antibiotic to FDA

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.