Navigation Links
FDA Advisory Committee Provides Opinion of DORIBAX(TM) for the Treatment of Hospital-Acquired Pneumonia
Date:7/16/2008

RARITAN, N.J., July 16 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted in favor of the efficacy and safety data for DORIBAX(TM) (doripenem for injection) for the treatment of hospital-acquired pneumonia, or nosocomial pneumonia (NP), and ventilator-associated pneumonia (VAP).

The committee voted that 500 mg of DORIBAX at both the one-hour and four-hour infusion regimens was safe (8-5) and effective (7-6). The committee did not agree on the appropriate non-inferiority margins for anti-infectives trials in nosocomial pneumonia.

The independent Advisory Committee provides recommendations based on its evaluation of the information presented. However, the final decision regarding approval of the drug is made by the FDA.

"We recognize that there is an important need for new antibiotics to treat these serious hospital infections," said Joanne Waldstreicher, M.D., Global Head, Drug Development, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. "We look forward to further discussions with the FDA as they complete their review of DORIBAX for the treatment of hospital-acquired and ventilator-associated pneumonia."

DORIBAX is an intravenous (IV) antibiotic for hospital use, and belongs to a class of antibacterial drugs called carbapenems. Carbapenems are important antibiotics to treat serious -- and sometimes life-threatening -- infections caused by a broad range of bacteria, which are characterized as Gram-negative and Gram-positive, based on a classification process that is used to identify the specific type of bacteria.

DORIBAX is approved in the U.S. for the treatment of complicated intra- abdominal infections (cIAI) and complicated urinary tract infections (cUTI), including pyelonephritis, due to susceptible bacteria, and is marketed by Ortho-McNeil, Division of Ortho-McNeil-
'/>"/>

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

Page: 1 2 3 4

Related biology technology :

1. Repair Stem Cell Institute Announces Science Advisory Board
2. Raptor Pharmaceuticals Expands Board of Directors and Scientific Advisory Board
3. ViroPharma Provides Update on Upcoming FDA Advisory Committee Meeting to Discuss Bioequivalence of Locally Acting Gastrointestinal Drugs
4. CDC Immunization Advisory Committee Recommends Two New Pediatric Vaccines from GlaxoSmithKline
5. U.S. Food and Drug Administration Advisory Committee Recommends Approval of Tolvaptan, an Investigational Treatment for Hyponatremia
6. Corgenix Expands Scientific Advisory Board
7. Deloitte Agrees to Acquire Recombinant Capital, A Leading Life Sciences Subscription Database and Advisory Services Firm
8. EnzySurge, Maker of DermaStream(TM), Announces the Formation of its Scientific Advisory Board
9. Viropharma Comments On Upcoming FDA Advisory Committee Meeting
10. DermTech Names Herbert A. Fritsche, Ph.D., Chief of Clinical Chemistry at M.D. Anderson Cancer Center to Companys Scientific Advisory Board
11. BioStorage Technologies Forms Scientific Advisory Board with Leading Life Science Experts
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)...  Roche (SIX: RO, ROG; OTCQX: RHHBY) announced ... a privately held company based in ... a big data platform for centralized management and ... proprietary on-market Genomic Management Solution, Bina-GMS 1 , ... fast and scalable analyses to maximize the value ...
(Date:12/19/2014)... Arkansas (PRWEB) December 18, 2014 ... to locate its pilot production facility and future ... develop and produce innovative new materials that safely ... chosen not only because of its historic, strong ... leaders’ efforts to attract leading edge, technology-based companies ...
(Date:12/19/2014)... In contrast to traditional LED lights where the ... uses proprietary LED technology to incorporate their spectra in ... is critical in low proximity installations. The Valoya L-series ... lifetime which is up to four times longer than ... cost was clearly higher when compared to traditional fluorescent ...
(Date:12/19/2014)... DALLAS , Dec. 18, 2014   ISN ... Health & Safety Performance Indicators publication series. ... hours of activity reported in 2013 within its online ... health and safety key performance indicator (KPI) statistics. ... Hiring Clients, U.S. publication is available in ...
Breaking Biology Technology:Roche acquires Bina Technologies and enters the genomic informatics market 2Roche acquires Bina Technologies and enters the genomic informatics market 3Technology Company TiFiber™ to Establish Production Facility in Fort Smith, Arkansas with Support from Local Investors 2Technology Company TiFiber™ to Establish Production Facility in Fort Smith, Arkansas with Support from Local Investors 3Technology Company TiFiber™ to Establish Production Facility in Fort Smith, Arkansas with Support from Local Investors 4ISN Releases Third Edition of US Contractor Health & Safety Performance Indicators Publication Series 2ISN Releases Third Edition of US Contractor Health & Safety Performance Indicators Publication Series 3
... LLC has been awarded a Phase I Small Business ... Institute on Aging. The project is focused on identifying ... (fat) that are regulated by a calorie restricted ... at LifeGen, the technology developed under the NIH ...
... In honor of National Chemistry Week (NCW), ... in San Diego, California, has joined with Herbert Hoover ... of chemistry in our everyday lives. National ... American Chemical Society (ACS) to unite local ACS ...
... Md., Oct. 21 United Therapeutics Corporation (Nasdaq: ... its third quarter 2010 financial results before market open ... will host a half-hour teleconference on Thursday, October 28, ... accessible by dialing 1-877-351-5881, with international callers dialing 1-970-315-0533. ...
Cached Biology Technology:LifeGen Technologies Awarded NIH Grant to Identify Biomarkers of a Calorie Restricted Diet in Adipose Tissue 2MicroConstants Celebrates National Chemistry Week by Teaching San Diego High School Students About the Drug Development Process 2
(Date:12/17/2014)... NEW YORK , Dec. 15, 2014 /PRNewswire-USNewswire/ ... a Good Clinical Practices (GCP) audit to confirm ... Administration (FDA) regulations. This accomplishment enables HITLAB to ... trials utilizing the highest principles for patient safety ... to improve global healthcare access, quality, and delivery ...
(Date:12/17/2014)... --Research and Markets ( http://www.researchandmarkets.com/research/9zq33j/global_chemical ) ... Chemical Sensor Market 2015-2019" report to their ... One major trend upcoming in this ... in biomedical applications. Chemical sensors help in recording ... during surgical procedures. The Global Chemical Sensor market ...
(Date:12/15/2014)... Research and Markets ( http://www.researchandmarkets.com/research/87pph8/global_facial ... "Global Facial Recognition Market 2015-2019" report to ... Facial recognition is a technology ... system measures the overall facial feature of a ... the distance between eyes. Facial recognition is used ...
Breaking Biology News(10 mins):HITLAB Completes GCP Audit for FDA Smart Device & App Compliance 2Global Chemical Sensor Market 2015-2019: Key Vendors are Abbott Laboratories, Bayer, Hoffmann La-Roche, Johnson & Johnson, NGK Spark Plugs and Robert Bosch 2Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 2Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 3
... Reinforcing its commitment to supporting high-quality cancer ... Foundation have again partnered with the American Association ... funding opportunities, the Landon Foundation-AACR INNOVATOR Award for ... Award for International Collaboration in Cancer Research. ...
... boost our understanding of the fragile marine environment, the ... for Environment, Fisheries & Aquaculture Science (Cefas) are launching ... existing collaboration between the two institutions and establish exciting ... climate change on the marine environment will influence much ...
... 10, 2008 Uncovering a rare, two-billion-year-old window into the ... have found our planets geological history is more complex than ... geosciences at UH, led a team of researchers in a ... new light on the mantle, the vast layer that lies ...
Cached Biology News:Landon Foundation-AACR INNOVATOR Awards 2Landon Foundation-AACR INNOVATOR Awards 3Landon Foundation-AACR INNOVATOR Awards 4New UEA-Cefas alliance launched 2Journey to the center of the earth: Discovery sheds light on mantle formation 2Journey to the center of the earth: Discovery sheds light on mantle formation 3
Agar, 5 lb. Bacteriological.Moisture: < 10%, ash: < 6.5%. Category: Nucleotides & Enzymes & Biochemicals, Ultrapure Biochemicals ....
Request Info...
... Intended to qualitatively ... in formalin-fixed, paraffin-embedded (FFPE) ... spreads, and cell preparations, ... Hybridization (CISH). Fluorescent In ...
Request Info...
Biology Products: