Navigation Links
ViroPharma Announces Meeting of FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology on Bioequivalence Recommendations for Oral Vancomycin Hydrochloride Products
Date:5/29/2009

EXTON, Pa., May 29 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) announced today that it will convene a meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to discuss bioequivalence recommendations for oral vancomycin hydrochloride capsule drug products. The meeting is scheduled for August 4, 2009. FDA will make background material available to the public no later than two days before the meeting at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.

Vancocin is the only approved product to treat Clostridium difficile-associated pseudomembranous colitis, one of the most common and devastating hospital-acquired infections. Clostridium difficile infection (CDI) can be severe, and without proper treatment, the associated complications of the disease can be deadly. The incidence of the disease observed in U.S. healthcare facilities more than doubled between 2000 and 2005; between 1999 and 2004, reported mortality rates from C. difficile in the U.S. more than quadrupled to 23.7 per million.

"ViroPharma views the convening of the advisory committee as a positive step towards open dialogue to discuss this very serious public health issue," commented Thomas Doyle, ViroPharma's vice-president, strategic initiatives. "ViroPharma will have an opportunity to address the Committee, and we look forward to what we hope will be a robust discussion of the many important issues raised by the Office of Generic Drugs' in vitro approach to bioequivalence for Vancocin."

About Clostridium difficile

One of the most serious problems facing the U.S. healthcare system today is hospital-acquired infections (HAIs). Clostridium difficile infection is one of the most co
'/>"/>

SOURCE ViroPharma Incorporated
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. ViroPharma to Present at Two May Healthcare Conferences
2. ViroPharma to Present at the Cowen & Company 29th Annual Healthcare Conference
3. ViroPharma to Host Investor Teach-In Educational Symposium on Hereditary Angioedema
4. ViroPharma to Release 2008 Fourth Quarter and Full Year Financial Results on February 24, 2009
5. ViroPharma Reports Results of Phase 3 Clinical Trial for Maribavir in Bone Marrow Transplant Patients
6. ViroPharma to Present at the 27th Annual J.P. Morgan Healthcare Conference
7. ViroPharma Provides Update on Vancocin(R)
8. ViroPharma Submits Supplemental Biologics License Application for Cinryze(TM) to Treat Acute Attacks of Hereditary Angioedema
9. ViroPharma To Present At The 20th Annual Piper Jaffray Healthcare Conference
10. ViroPharma to Discuss Commercialization and Launch of Cinryze(TM) on November 5, 2008
11. ViroPharma Incorporated Reports Third Quarter 2008 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2014)... Sugar Land, TX (PRWEB) July 30, 2014 ... pharmacy recently announced their plans to move to a new ... been announced, but they will be moving soon. , MedX ... 6302 W Broadway in Pearland, TX 77581. This is the ... than their current one and will include a drive thru ...
(Date:7/30/2014)... 2014 Ticket Down is a ... vs. Chivas Guadalajara friendly exhibition match at the Red ... the one team that was left standing as the best ... through the world’s largest football competition and even embarrassed the ... to the cup. Germany was led by seven players that ...
(Date:7/30/2014)... 30, 2014 Conducting Advanced Root ... Thinking Skills and Innovative Techniques to Improve the ... and FDAnews**, Sept. 17-18, 2014 – Raleigh, NC, ... #1 reason for 483 observations since 1997. , ... a successful CAPA program has never been more ...
(Date:7/30/2014)... in sub-Saharan Africa is being revitalized and expanded ... enrollment, broadening curricula, upgrading Internet access and providing ... In the first substantial publication by participants of ... more than 225 authors detailed progress being made ... a supplement being published today by the journal ...
(Date:7/30/2014)... artemisinin, the main drug to treat malaria, is ... Plasmodium falciparum ( P. falciparum ) parasites ... by a genetic mutation in the parasites. However, ... to a standard three-day coursehas proved highly effective ... published today in the New England Journal ...
Breaking Medicine News(10 mins):Health News:MedX Pharmacy Relocates to New Facility 2Health News:Bayern Munich vs. Chivas Guadalajara Tickets Red Bull Arena: Ticket Down Slashes Ticket Prices for Chivas Guadalajara vs. Bayern Munich in Harrison, NJ 2Health News:Bayern Munich vs. Chivas Guadalajara Tickets Red Bull Arena: Ticket Down Slashes Ticket Prices for Chivas Guadalajara vs. Bayern Munich in Harrison, NJ 3Health News:FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC 2Health News:FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC 3Health News:FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC 4Health News:Journal supplement details progress in African medical education 2Health News:Journal supplement details progress in African medical education 3Health News:Resistance to key malaria drug spreading at alarming rate in Southeast Asia 2
... -- Teenage girls who develop post-traumatic stress disorder after being ... research shows. In the study, researchers analyzed data collected ... part in a national telephone survey and were interviewed up ... time, 270 of the girls (15 percent) reported sexual victimization. ...
... Chicago College of Medicine have been awarded more than $11.7 ... The study, part of a multi-pronged investigation into acute ... Lung and Blood Institute, one of the National Institutes of ... acute respiratory distress syndrome, result from pulmonary edema -- leaky ...
... , FRIDAY, July 29 (HealthDay News) -- An ... -- a specific breed of dog known for truffle hunting, ... newly identified gene has enabled the development of a DNA ... for humans, providing new perspective on the development of a ...
... is available in Spanish . Patients suffering ... attacked and pursued, with the particularity that they express them ... Neurology has published the third consecutive work in five ... The first work showed in 2006 that 45% ...
... ethnic groups are more likely than others to store dangerous fat ... new study. This organ-hugging fat, which can lead to ... South Asia, the Canadian researchers reported in the July 28 online ... study showed South Asians have less space to store fat below ...
... bikers, brains, may also be contributing to hearing loss. ... out why. The distinctive roar of a Harley,s ... source of noise for motorcyclists is actually generated by ... speeds, the sound can exceed safe levels. Now, scientists ...
Cached Medicine News:Health News:Sexual Assault Doesn't Cause Binge Drinking in Girls: Study 2Health News:$12 million NIH grant to study acute lung injury 2Health News:New Dog Gene May Shed Light on Childhood Epilepsy 2Health News:REM sleep behavior disorder is a risk factor for Parkinson's disease 2Health News:Some Ethnic Groups More Vulnerable to Dangerous Fat 2
(Date:7/30/2014)... , July 30, 2014   Bluegrass Vascular ... on innovating lifesaving devices and methods for vascular ... in Series A financing, which was led by ... the deal will allow Bluegrass Vascular to obtain ... System, enhance manufacturing capabilities, and proceed with US ...
(Date:7/30/2014)... SUNNYVALE, California , July 30, 2014 /PRNewswire/ ... GPU technology and CUDA programming expertise to big ... other markets  eInfochips, a leading engineering ... to clients to develop NVIDIA GPU-powered solutions for ... , high-performance computing (HPC), industrial ...
(Date:7/29/2014)... 29, 2014 /PRNewswire-iReach/ -- The global microbial identification ... methods, applications, end users, and geographies. Genotypic technology ... microbial identification market. This favorable growth is attributed ... and the time required for microbial identification along ... Furthermore, genotypic methods have high applications in clinical ...
Breaking Medicine Technology:Bluegrass Vascular Technologies Raises $4.5M Series A Financing Led By Targeted Technology Funds 2eInfochips to Develop NVIDIA GPU-powered Solutions for Aerospace and Defense, Medical Imaging, HPC and Visual Computing 2Microbial Identification Market Growing at 5.9% CAGR to 2019: Global Forecast in New Research Report Available at ReportsnReports.com 2Microbial Identification Market Growing at 5.9% CAGR to 2019: Global Forecast in New Research Report Available at ReportsnReports.com 3Microbial Identification Market Growing at 5.9% CAGR to 2019: Global Forecast in New Research Report Available at ReportsnReports.com 4Microbial Identification Market Growing at 5.9% CAGR to 2019: Global Forecast in New Research Report Available at ReportsnReports.com 5Microbial Identification Market Growing at 5.9% CAGR to 2019: Global Forecast in New Research Report Available at ReportsnReports.com 6
... Nov. 10, 2011 Throughout the healthcare industry, compliance ... relations (PTR) groups are tightening as increased regulations intensify ... the pace of activity cycles are slowing and more ... Nearly 90% of pharma PTR groups feel ...
... HONOLULU, Nov. 10, 2011 Eli Lilly and Company ... Executive Officer John C. Lechleiter, Ph.D., today said new ... bring innovation to patients are needed to assure improved ... Lechleiter,s comments come as the United States hosts ...
Cached Medicine Technology:Restrictive Compliance Environment Weakens Professional and Trade Relations Group Impact 2Lilly CEO Lechleiter Outlines Opportunities for Improved Health and Economic Growth in Asia-Pacific Region 2Lilly CEO Lechleiter Outlines Opportunities for Improved Health and Economic Growth in Asia-Pacific Region 3Lilly CEO Lechleiter Outlines Opportunities for Improved Health and Economic Growth in Asia-Pacific Region 4
The torso blanket is designed to affix to the lower abdominal area and cover the upper half of the body....
The torso blanket is designed to affix to the lower abdominal area and cover the upper half of the body....
Cocoon Disposable Patient Warming Blankets are specially designed to prevent hypothermia and maintain normothermia in your patients. The soft warm coloured material is strong and resists tearing and ...
The fabric is antistatic and non-linting and is both oil and water repellent.These superior blankets are an environmental friendly alternative to disposable blankets....
Medicine Products: