FDA Approves Doripenem (Doribax) Injection for Complicated GI Infections

ROCKVILLE, Md., Oct. 18 -- The FDA has approved doripenem (Doribax) injection for treatment of hospitalized patients with complicated urinary tract and intra-abdominal infections.
At the dose approved (500 mg IV infusion), the agency noted that the drug demonstrated a cure rate comparable to levofloxacin for complicated urinary tract infections and to meropenem for complicated intra-abdominal infections in multi-center, multinational trials.
Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer and acting director of the Center for Drug Evaluation and Research, said doripenem was "a significant new drug."
In clinical trials 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. Nor has the drug been studied in pregnant women, so it should be used during pregnancy only if clearly needed.
Doripenem is manufactured by Johnson and Johnson.