RARITAN, N.J., March 6 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C., today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the second New Drug Application for the antibiotic DORIBAX(TM) (doripenem for injection). The application, submitted in June 2007, seeks approval to market DORIBAX to treat nosocomial, or "hospital-acquired," pneumonia and ventilator-associated pneumonia, which occurs in patients who are on mechanical ventilation because they cannot breathe on their own.
The FDA extended the review period by three months to provide time for a full review of the application after receiving additional information it had requested from the company.
DORIBAX is already FDA-approved to treat complicated urinary tract and complicated intra-abdominal infections and is marketed by Ortho-McNeil(TM), Division of Ortho-McNeil-Janssen Pharmaceutical Services, Inc., in the U.S. The use of DORIBAX to treat complicated urinary tract and complicated intra-abdominal infections and nosocomial pneumonia, including ventilator-associated pneumonia, currently is under regulatory review in Europe, Canada and in other countries. DORIBAX is licensed from Shionogi & Co., Ltd.
INDICATIONS
DORIBAX is indicated as a single agent for the treatment of: complicated intra-abdominal infections caused by susceptible strains of E. coli, K. pneumoniae, P. aeruginosa, B. caccae, B. fragilis, B. thetaiotaomicron, B. uniformis, B. vulgatus, S. intermedius, S. constellatus or P. micros, and for the treatment of complicated urinary tract infections, including pyelonephritis, caused by susceptible strains of E. coli, including cases with concurrent bacteremia, K. pneumoniae, P. mirabilis, P. aeruginosa, or A. baumannii.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORIBAX and other antibacterial drugs, DORIBAX should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
IMPORTANT SAFETY INFORMATION
DORIBAX is contraindicated in patients with known serious hypersensitivity to doripenem or other carbapenems or in patients who have demonstrated anaphylactic reactions to beta-lactams.
Serious and occasionally fatal hypersensitivity (anaphylactic) and serious skin reactions have been reported in patients receiving beta-lactam antibiotics. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. If an allergic reaction to DORIBAX occurs, discontinue the drug. Serious acute anaphylactic reactions require emergency treatment with epinephrine and other emergency measures, including oxygen, IV fluids, IV antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated.
Carbapenems may reduce serum valproic acid concentrations to subtherapeutic levels, resulting in loss of seizure control. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations cannot be maintained in the therapeutic range or seizures occur.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two (2) months after administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
When DORIBAX has been used investigationally via inhalation, pneumonitis has occurred. DORIBAX should not be administered by this route.
Safety and effectiveness in pediatric patients have not been established.
The most common adverse reactions (greater than or equal to 5%) observed in clinical trials were headache, nausea, diarrhea, rash and phlebitis.
For more information visit www.DORIBAX.com.
Ortho-McNeil(TM) is committed to providing innovative, high-quality prescription medicines and resources for healthcare providers and their patients in hospitals and other care facilities. For more information, visit www.ortho-mcneil.com.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
