Navigation Links
ViroPharma Announces Support by Advisory Committee of The Office of Generic Drugs Proposed Guidelines for Developing Generic Versions of Oral Vancomycin Hydorchloride
Date:8/4/2009

generic products that:

(a) contain the same active and inactive ingredients in the same amounts as Vancocin( )HCl capsules;

(b) meet currently accepted standards for assay, potency, purity, and stability (equivalent to those in place for Vancocin( )HCl capsules); and

(c) are manufactured according to cGMP.

According to ViroPharma, the proposed in vitro test conditions do not mimic the in vivo environment of the CDI patient and the qualitative and quantitative sameness (Q1Q2) is inadequate given formulation and critical manufacturing process controls and lacks correlation with clinical effects. The company also underscored that the adoption of bioequivalence guidelines is precedent setting and patient safety must be a primary concern.

About Vancocin

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.

About Clostridium difficile Infection (CDI)

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 common and devastating HAIs. The incidence of C. diff observed in U.S. healthcare facilities more than doubled between 2000 and 2005; between 1999 and 2004, reported mortality rates from C. diff in the U.S. more than quadrupled to 23.7 per million. Elderly patients exposed to antibiotics, long-
'/>"/>

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

Page: 1 2 3 4

Related medicine news :

1. ViroPharma Incorporated Reports Second Quarter 2009 Financial Results
2. ViroPharma to Release 2009 Second Quarter Financial Results on July 29, 2009
3. ViroPharma Announces Appointment of Frank Baldino, Jr., Ph.D. to Board of Directors
4. ViroPharma Announces Meeting of FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology on Bioequivalence Recommendations for Oral Vancomycin Hydrochloride Products
5. ViroPharma to Present at Two May Healthcare Conferences
6. ViroPharma to Present at the Cowen & Company 29th Annual Healthcare Conference
7. ViroPharma to Host Investor Teach-In Educational Symposium on Hereditary Angioedema
8. ViroPharma to Release 2008 Fourth Quarter and Full Year Financial Results on February 24, 2009
9. ViroPharma Reports Results of Phase 3 Clinical Trial for Maribavir in Bone Marrow Transplant Patients
10. ViroPharma to Present at the 27th Annual J.P. Morgan Healthcare Conference
11. ViroPharma Provides Update on Vancocin(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... Lake City, UT (PRWEB) July 25, 2014 ... basketball court surfaces for the recent Nike National ... and the current United States Junior National Tournament ... through July 25. , The flooring for these prestigious ... totaling more than 300,000 square feet of playing surface ...
(Date:7/25/2014)... 25, 2014 Florida Hospital and MOSI officially ... organizations for years to come and make a difference in ... $2 million dollar check to provide the support needed to ... enable MOSI to transform the IMAX Dome Theatre from film ... the only IMAX Dome Theatre in the state of Florida, ...
(Date:7/25/2014)... AttorneyOne.com, a recognized authority on law, update the website ... Ibuprofen and Oxcarbazepine Tablets . , The FDA ... one lot of Oxcarbazepine Tablets, by American Health Packaging (AHP), ... used for the treatment of certain types of seizures in ... recall is that Lot #142588, Expiration Date, 01/2016 of Ibuprofen ...
(Date:7/25/2014)... 2014 A new study of participants in ... are published today in Cancer , found evidence that ... who had an abnormal finding on a lung cancer screening ... life than did those who were screened and found to ... to the researchers. “We expected that participants with an abnormal ...
(Date:7/25/2014)... This is a professional and ... Galactooligosaccharides (GOS) industry in Global and China. ... industry, including definitions, applications and industry chain structure. ... are provided with a focus on history, developments, ... comparison between the international and Chinese situation is ...
Breaking Medicine News(10 mins):Health News:Sport Court Provides All Sports Flooring for Basketball Events in Chicago and Washington D.C. 2Health News:Florida Hospital Donates a Two Million Dollar Transformational Gift to the Museum of Science and Industry (MOSI) 2Health News:Florida Hospital Donates a Two Million Dollar Transformational Gift to the Museum of Science and Industry (MOSI) 3Health News:Florida Hospital Donates a Two Million Dollar Transformational Gift to the Museum of Science and Industry (MOSI) 4Health News:Ibuprofen and Oxcarbazepine Tablets Recalled: AttorneyOne Monitors and Keep Consumers Informed 2Health News:Full Explanation Reduces Seniors’ Worries about Lung Cancer Screening 2Health News:Full Explanation Reduces Seniors’ Worries about Lung Cancer Screening 3Health News:Full Explanation Reduces Seniors’ Worries about Lung Cancer Screening 4Health News:Full Explanation Reduces Seniors’ Worries about Lung Cancer Screening 5Health News:GOS Market (Galacto-oligosaccharides) Development in Global & China Regions Now Available at DeepResearchReports.com 2Health News:GOS Market (Galacto-oligosaccharides) Development in Global & China Regions Now Available at DeepResearchReports.com 3
... , TIANJIN, China, June 3 ... by Pfizer Inc. as the 2008 Top Intermediates CMO,Award, ... and drug product,facility, despite the current challenging economic environment. ... of Chemical,Development and is ready to help expand and ...
... It, Too! , , ATLANTA, June 3 We,ve all ... magazines ... celebrity moms flaunting their beautiful beach bodies in bikinis. ... which leaves the rest of us wondering how they got so ... trainer Susie Shina gained weight after having kids. The extra pounds ...
... 3 Gene Network Sciences, Inc. (GNS) today announced ... The University of Connecticut Health Center,s Carole ... parties will incorporate genetic, genomic and clinical data ("3-D ... be used to identify the best treatments for individual ...
... MINNEAPOLIS, June 3 ATS Medical, Inc. (Nasdaq: ... surgery products and services, today announced participation in the ... Meeting in San Francisco on June 3-6, 2009. ... surgeons from around the world whose interests include the ...
... ... , ... (Vocus) June 3, 2009 -- Morehead Associates will host a webinar on ... , ,Retaining skilled, engaged physicians is critical to the success of health systems across ...
... ... products and other services. , ... San Jose, Calif. (PRWEB) June 3, 2009 -- The Glowan Consulting Group, ... a new on-line store allowing clients and partners to purchase their suite of Leadership ...
Cached Medicine News:Health News:Asymchem Continues to Maintain a Good Running Posture, Despite Economic Crisis 2Health News:Asymchem Continues to Maintain a Good Running Posture, Despite Economic Crisis 3Health News:Asymchem Continues to Maintain a Good Running Posture, Despite Economic Crisis 4Health News:Celebrity Moms Make Headlines in Their New Bikinis 2Health News:Gene Network Sciences Announces Cancer Collaboration with University of Connecticut Health Center's Neag Comprehensive Cancer Center 2Health News:Gene Network Sciences Announces Cancer Collaboration with University of Connecticut Health Center's Neag Comprehensive Cancer Center 3Health News:ATS Medical Announces Participation in the International Society for Minimally Invasive Cardiothoracic Surgery Meeting 2Health News:ATS Medical Announces Participation in the International Society for Minimally Invasive Cardiothoracic Surgery Meeting 3Health News:ATS Medical Announces Participation in the International Society for Minimally Invasive Cardiothoracic Surgery Meeting 4Health News:Morehead Webinar on Driving Physician Retention through Engagement 2Health News:Glowan Consulting Announces New On-Line E-Commerce Site 2
(Date:7/25/2014)... , July 25, 2014 GrowBLOX Sciences, Inc. (OTCQB: ... Memorandum of Understanding ("MOU") with LaurelCo, LLC, an ... acquisition of both cultivation and dispensary medical marijuana licenses in ... the MOU, GBLX will acquire a 20% equity interest in ... GrowBLOX TM growing chambers, as well as all technology ...
(Date:7/25/2014)... , July 25, 2014  Acsis Inc., the ... and serialization solutions, has recently posted an article, ... addresses current and future needs for companies, extended ... old supply chain model no longer work today.  ... including the growth of mobile technology, machine to ...
(Date:7/25/2014)... MEXICO CITY , July 25, 2014 ... a Latin American healthcare sciences publisher, launched a library ... on conditions such as cancer and heart disease. Healthcare ... most up-to-date information to deliver better patient care. ... rapidly, with many relying on smartphones and tablets to ...
Breaking Medicine Technology:GrowBLOX Sciences, Inc. Partners with LaurelCo, LLC to Obtain Licenses to Cultivate and Dispense Medical Marijuana in Illinois 2GrowBLOX Sciences, Inc. Partners with LaurelCo, LLC to Obtain Licenses to Cultivate and Dispense Medical Marijuana in Illinois 3Acsis Addresses Questions on the Modern Supply Chain 2Healthcare Sciences Publisher PLM and IBM Speed Access to Medical Information to Deliver Better Patient Care with Mobile 2Healthcare Sciences Publisher PLM and IBM Speed Access to Medical Information to Deliver Better Patient Care with Mobile 3Healthcare Sciences Publisher PLM and IBM Speed Access to Medical Information to Deliver Better Patient Care with Mobile 4
... study presented at the American Association of Physicists in Medicine ... showed that 18FDG dose for Positron Emission Mammography (PEM) may ... quality. PEM scanners are high-resolution breast PET systems ... of a lesion.  The metabolic view assists physicians to make ...
... Aug. 23 Encorium Group, Inc. (Nasdaq: ENCO ... studies in over 30 countries for many of the world,s ... to commence a rights offering for up to 3,401,151 shares ... offering, each stockholder of record as of August 11, 2010 ...
Cached Medicine Technology:Preliminary Research Results Suggest up to 70% Reduction in Dose for Positron Emission Mammography Imaging 2Preliminary Research Results Suggest up to 70% Reduction in Dose for Positron Emission Mammography Imaging 3Encorium Group, Inc. Announces Terms of Proposed Rights Offering 2Encorium Group, Inc. Announces Terms of Proposed Rights Offering 3Encorium Group, Inc. Announces Terms of Proposed Rights Offering 4
Use the Mo Bio Vortex Adapter in conjunction with the Vortex Genie 2 for rapid bead beating procedures. Using the Mo Bio Vortex Adapter is an inexpensive alternative to other bead beating and Fast Pr...
... Combines BchiVac V-500, water-cooled secondary condenser ... housing Model V-500 is a powerful PTFE ... vacuum applications. Applications Ideally ... rotary evaporators Laboratory vacuum source ...
... secondary condenser to trap residual solvent vapors ... vacuum pump designed to handle most vacuum ... for use with up to two rotary ... instruments including vacuum ovens, concentrators, gel dryers, ...
Universal vacuum pump (capacity 34 L/min, 8 mbar vacuum abs.)...
Medicine Products: