Navigation Links
FDA Extends Review Timeline for Additional Indication for Antibiotic DORIBAX(TM)
Date:3/6/2008

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 http://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 http://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.

CONTACTS

Media: Amy Firsching, 908-218-7583 or Samina Bari, 908-218-6483

Investor Relations: Lesley Fishman, 732-524-3922 or Louise Mehrotra,

732-524-6491


'/>"/>
SOURCE Johnson & Johnson Pharmaceutical Research & Development,L.L.C.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Siemens Extends Tender Offer for Acquisition of Dade Behring
2. Global Med Technologies(R) Extends Its Worldwide Outreach
3. Baxa Corporation Extends Global Reach With New Distribution Agreements in Colombia and the Dominican Republic
4. NIH/NCI renews and extends nationwide license for Genomatix software and databases
5. Design Resource Extends Support for Orthopaedic and Cardiovascular Devices
6. Kerry Extends, Improves Small Business Innovation Program
7. amfAR Appoints New Leadership as AIDS Research Organization Extends Its Global Reach
8. Emdeon Business Services Extends Market Leadership With New Dental Eligibility Payers
9. QMed, Inc. Extends Agreement & Receives $550,000 Performance Bonus
10. Roche Extends Tender Offer for Ventana
11. Oncology Physician Resource (OPR) Extends Agreement With OTN and Onmark as Oncology Services Partner
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2017)... ... June 23, 2017 , ... All-Star Insurance, a family managed ... clients throughout eastern Texas, is announcing the launch of a new charity drive to ... statistics in the United States reveal that an estimated 252, 710 new cases of ...
(Date:6/22/2017)... ... June 22, 2017 , ... Plastic Surgery Associates is proud to ... for 2017. Each year, research and information firm, Castle Connolly, releases their list of ... 2015, this marks the 3rd time that Dr. Canales has been recognized ...
(Date:6/22/2017)... ... ... Despite its pervasiveness, many physicians are unfamiliar with how best to treat ... practice. Now, however, a timely review has been published in the Journal of ... NeuP and educating preclinical scientists on its diagnosis and choice of treatment. , The ...
(Date:6/22/2017)... (PRWEB) , ... June 23, 2017 , ... ... in the fight against hunger on June 21, 2017, at the Emeryville Center ... food insecurity and malnutrition around the world. , Rise Against Hunger (formerly Stop ...
(Date:6/20/2017)... , ... June 20, 2017 , ... After months of negotiations, FaceCradle USA is proud ... on Wednesday, June 21. , “Introducing our product on QVC is something we all ... promote our travel pillow to more than 90 million homes in the United States,” said ...
Breaking Medicine News(10 mins):
(Date:6/8/2017)... 2017  StatLab Medical Products ("StatLab" or ... of diagnostic supplies for the anatomic pathology ... Company LP ("Cressey & Company"), a healthcare-focused ... investment in the Company. Cressey & Company ... selling shareholder, Prairie Capital, L.P., with certain ...
(Date:6/5/2017)... , June 5, 2017 Kohll,s Pharmacy ... the United States . The Raizer is ... a fallen person up to an almost-standing position ... and operated by one assistant and does not ... is simple enough that a child can operate it, ...
(Date:5/30/2017)... , May 30, 2017 Hill-Rom Holdings, Inc. ... Annual Global Healthcare Conference on Tuesday, June 13, 2017, ... John Greisch , Hill-Rom,s president and chief executive officer, is ... The live audio webcast can be accessed at http://ir.hill-rom.com/events.cfm ... conclusion of the live event through September 13, 2017. ...
Breaking Medicine Technology: