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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
October 17, 2007

Media Inquiries:
Christopher Kelly, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Approves New Drug to Treat Complicated Urinary Tract and Intra-Abdominal Infections

The U.S. Food and Drug Administration has approved doripenem injection, 500 mg intravenous infusion, for the treatment of complicated urinary tract and intra-abdominal infections. Doripenem injection, sold under the trade name Doribax, has been shown to be active against several strains of bacteria.

“This is a significant new drug in the treatment of hospitalized patients with serious bacterial infections,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research.

In several multi-center, multinational studies, doripenem was shown to have a cure rate comparable to the currently prescribed medications levofloxacin, for complicated urinary tract infections, and meropenem, for complicated intra-abdominal infections.

The most common adverse reactions reported were headache, nausea, diarrhea, rash, and phlebitis. In addition, allergic reactions have occurred and some may require immediate treatment.

The safety and effectiveness of doripenem injection in pediatric patients have not been established. Doripenem has not been studied in pregnant women, and the drug should be used during pregnancy only if clearly needed.

Doripenem injection is manufactured by Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, N.J.

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