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 in
'/>"/>

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

0

GOOD

Page: 1 2 3

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:5/25/2013)... 25, 2013 The Slim Weight Patch has ... results. This is due to the highly sought after ingredients ... weight patch offers an extra 2 months supply & premium ... and get the body you desire faster than ever. , ... , With Slim weight patch consumers can observe instant ...
(Date:5/25/2013)... 2013 For college students, few ... Increasingly, they are turning to prescription stimulants like ... For more on this, go to http://www.sciencedaily.com/releases/2013/05/130501145151.htm ... warns that students who pick up Adderall, “just ... for developing a physical and psychological dependency. While ...
(Date:5/25/2013)... 25, 2013 Superior Magnetics for Pain ... in seconds for arthritis, tendinitis and bursitis , Pain ... relief products announced a magnetic bracelet so ... for pain relief is demonstrated at fairs and festivals. ... Gauss magnets and has customers often report pain relief ...
(Date:5/25/2013)... 25, 2013 http://www.resource4thepeople.com/defectivedrugs/Actos-Bladder-Cancer-Lawsuit.html , ... judge's overturning of a jury's award of $6.5 million ... trial* in the country over allegations that the diabetes ... files. , The judge in the case ruled that ... his cancer was caused by the medication.** , Bloomberg ...
(Date:5/24/2013)... FL (PRWEB) May 25, 2013 The ... Cellulite Whisperer ® products from Sublime Beauty®. The ... to diminish cellulite, and many of the ingredients are ... deal with and is dreaded by many women," says ... concentrated holistic plan, women can diminish their cellulite." The ...
Breaking Medicine News(10 mins):Health News:Slim Weight Patch Advanced Weight Loss System Offers Extra Two Month Supply and Membership for Maximum Weight Loss 2Health News:Addiction and Drug Abuse: Study Drug Adderall Abuse Spikes During Finals 2Health News:Magnetic bracelet relieves pain in seconds announces Superior Magnetics 2Health News:Alleged Actos Bladder Cancer Lawsuits Update: $6.5 Million Verdict Overturned as Resource4thePeople Attorneys Continue to Accept Cases 2Health News:Alleged Actos Bladder Cancer Lawsuits Update: $6.5 Million Verdict Overturned as Resource4thePeople Attorneys Continue to Accept Cases 3Health News:Alleged Actos Bladder Cancer Lawsuits Update: $6.5 Million Verdict Overturned as Resource4thePeople Attorneys Continue to Accept Cases 4Health News:"Get Ready for Summer Sale" at Sublime Beauty® Continues: New Cellulite Whisperer® Products 2
... Aug. 19 (HealthDay News) -- At 3 years of age, Pablo ... He also had frequent severe constipation, so much so that he ... of Alexandria, Va. Because of the prolapse, a condition in ... doctors worried that the boy, who is now 13, had cystic ...
... delicti is a plain flacon from among the possessions of ... exhibit in the permanent collection of the Egyptian Museum of ... the vessel may have held a deadly secret. This is ... Helmut Wiedenfeld from the university,s Pharmacology Institute just discovered. After ...
... (August 19, 2011) Antibiotics can help ward off serious ... catheters for their dialysis treatments. But if antibiotics are used ... to the drugs. A new randomized controlled clinical trial ... used to treat other serious infections may be a safe ...
... News) -- Cases of Legionnaire,s disease in the United States ... report shows. And while Legionnaires, disease is serious and ... for concern, most people recover with antibiotic treatment, officials said. ... Centers for Disease Control and Prevention rose from 1,110 in ...
... 18 (HealthDay News) -- Two gene variations that increase smokers, ... Smokers with the variants also tend to smoke more and ... Researchers at the Centre for Addiction and Mental Health in ... cancer and 443 current or former smokers without cancer. ...
... Society congratulates Dietrich Manzey, Maria Luz, Stefan Mueller, ... receiving the 2011 Human Factors Prize for their ... Assistance on Performance, Waorkload, Situation Awareness, and Acquisition ... is health-care ergonomics, broadly defined to include research ...
Cached Medicine News:Health News:Gluten-Free Set This Boy Free 2Health News:Deadly medication? 2Health News:Deadly medication? 3Health News:Acne-treating antibiotic cuts catheter infections in dialysis patients 2Health News:Cases of Legionnaire's Disease Tripled in 10 Years 2Health News:Gene Variants That Boost Lung Cancer Risk Identified 2Health News:Paper on automation in surgery wins 2011 Human Factors Prize for Excellence in HF/E Research 2Health News:Paper on automation in surgery wins 2011 Human Factors Prize for Excellence in HF/E Research 3Health News:Paper on automation in surgery wins 2011 Human Factors Prize for Excellence in HF/E Research 4
(Date:5/23/2013)... SAINT PAUL, Minn. , May 23, 2013 /PRNewswire/ ... Angeion Corporation), a global medical technology company, today scheduled ... the second quarter of fiscal year 2013, ended April ... ET on Thursday, May 30, 2013. The Company will ... year 2013 after the markets close on Thursday, May ...
(Date:5/23/2013)... , May 23, 2013  Hadasit Bio-Holdings Ltd. ... of biotech companies, based on intellectual property developed ... Israel ,s foremost medical research center, today ... Ltd., received significant funding from the Israeli Ministry ... Scientist (OCS) to support product development and advance ...
(Date:5/23/2013)... SANTA MONICA, Calif. , May 23, 2013 /PRNewswire-USNewswire/ ... of a program that would have required them to ... announced today by Consumer Watchdog and Whatley Kallas LLC.  ... San Diego Superior Court, alleged that Blue Cross,s mandatory ... HIV/AIDS patients, threatening their health and privacy. ...
Breaking Medicine Technology:MGC Diagnostics Corporation to Report Second Quarter Fiscal 2013 Financial Results on Thursday, May 30, 2013 2Hadasit Bio-Holdings Ltd. Portfolio Company - Cell Cure Neurosciences Ltd. Received Additional Government Support 2Blue Cross To Allow HIV/AIDS Patients to "Opt-Out" of Mandatory Mail-Order Rx Drug Program, Announces Consumer Watchdog 2Blue Cross To Allow HIV/AIDS Patients to "Opt-Out" of Mandatory Mail-Order Rx Drug Program, Announces Consumer Watchdog 3
A One Piece Support Garment - any length or size...
Body Suit w/Bra torso, Front Closure...
Gynecomastia Vest...
Ideal for breast compression and contouring breast cups....
Medicine Products: