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Oct19
FDA Approves Doribax

Doribax, an intravenous infusion that has been shown to be affective against several strains of bacteria, has been approved by the U. S. Food and Drug Administration.

The doripenem injection is indicated for the treatment of complicated urinary tract infections and intra-abdominal infections. “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.

Iortho-mcneil.jpgn multi-center studies, doripenem has a cure rate comparable to the currently used medication levofloxacin. Common adverse reactions were headache, nausea, diahhrea, rash and plebitis. Should an allerigic reaction occur, it may require immediate treatment.

Doribax belongs to a class of antibacterial agents calls carbapenems. Carbapenems are important in treating serious infections caused by Gram-positive and Gram negative bacteria.

"New agents are urgently needed to effectively treat Gram-negative and Gram-positive bacterial infections," said Joseph Solomkin, M.D., Professor of Surgery and Director of Research, University of Cincinnati College of Medicine. "The introduction of DORIBAX is important for the treatment of these serious infections as fewer antibiotics appear to effectively eradicate many troublesome bacteria, such as Pseudomonas."

[Source: Ortho-McNeil]

 

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