Navigation Links
ViroPharma Provides Update on Vancocin(R)
Date:1/8/2008

rective

actions;

-- August 2007 Docket submission by ViroPharma providing comments on the

FDA's Draft Guidance for Industry on Bioequivalence Recommendations for

Specific Products; and

-- May 2007 Docket submission by ViroPharma discussing the bioequivalence

issue in more detail and clarifying the types of testing ViroPharma

believes are required to demonstrate bioequivalence and to provide an

adequate basis for determining whether a BCS-based biowaiver to

establish bioequivalence for Vancocin results in an acceptable level of

risk to patients and public health.

ViroPharma remains committed to assuring the safety of patients suffering from C. difficile infection and continues to oppose vigorously any bioequivalence approach considered for use in approving generic formulations of Vancocin that does not require rigorous scientific methods developed through public process to demonstrate bioequivalence. The company is committed to ensuring safety and efficacy of the drug consistent with good medicine, science, and the law.

C. difficile is a bacterium, which under certain circumstances, typically after antibiotic therapy, can colonize the lower gastrointestinal tract where it may produce toxins which cause inflammation of the colon and diarrhea. Without proper treatment, the associated complications of the disease can be deadly. Advanced age, gastrointestinal surgery/manipulation, long length of stay in healthcare settings, a serious underlying illness and compromised immunity are conditions associated with increased risk of disease. According to the U.S. Centers for Disease Control and Prevention (CDC), there are an estimated 400,000 to 500,000 CA-CDAD and HA-CDAD cases annually based on 2004 data.

About the OPS

The OPS, an office within the FDA's Center for Drug Evaluation and Research (CDER), oversees the activities of chemistry, manufacturing and controls re
'/>"/>

SOURCE ViroPharma Incorporated
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. ViroPharma Augments Senior Management
2. ViroPharma to Present at the 26th Annual JP Morgan Healthcare Conference
3. ViroPharma Receives European Orphan Drug Designation for CAMVIA(TM)
4. ViroPharma Incorporated Reports Third Quarter and Nine-Month 2007 Financial Results
5. ViroPharma to Present at the UBS Global Life Sciences Conference
6. ViroPharma to Present at the Maxim Group First Annual Growth Conference
7. HearAtLast Holdings, Inc. Provides Shareholder Update
8. Mayo Clinic Proceedings provides forum for debate about capital punishment
9. Kaiser Permanente Provides $1.4 Million in Holiday Gifts to 40 Metro Atlanta Nonprofits
10. Akela Pharma provides corporate update
11. Genomic Health Announces Oncotype DX(R) Provides Additional Prognostic Benefit in Patients Assessed With Adjuvant Online
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/4/2015)... ... July 04, 2015 , ... Tyler Boden, ... of technical sales expertise from the North American Board of Certified Energy Practitioners ... the most highly respected and well established national certification organization for renewable energy ...
(Date:7/3/2015)... ... 03, 2015 , ... On June 30th SEO authority and ... system called "Page One Engine" . The program, which has been hailed ... from several well-known marketers. HonestyFirstReviews.com's Tiffany Hendricks has joined the party, publishing an ...
(Date:7/3/2015)... ... July 03, 2015 , ... Renowned rhinoplasty surgeon ... for the 2016 Dallas Rhinoplasty Symposium . To be held from March 4th ... will be held at the Westin Galleria Dallas. , Designed to take participants from ...
(Date:7/3/2015)... ... 2015 , ... The Erie County Bar Association Institute of ... Association welcomed speaker C. Daniel McGillicuddy Esq. of William Mattar Law Offices. ... these types of cases. , Each year, New York State residents are hospitalized ...
(Date:7/3/2015)... ... ... Jennifer Renee Hanes, DO is the new Medical Director of its Sienna ... freestanding emergency rooms in the United States. , “We are excited to welcome Dr. ... Medical Director of First Choice Emergency Room, Dr. James M. Muzzarelli. , Dr. ...
Breaking Medicine News(10 mins):Health News:Local Solar Professional Earns Industry's Most Prestigious Certification 2Health News:Local Solar Professional Earns Industry's Most Prestigious Certification 3Health News:Page One Engine - Review Of Dori Friend's SEO Training Course Released 2Health News:Dr. Rod J. Rohrich Announces the Dates for 2016 Dallas Rhinoplasty Symposium 2Health News:Dr. Rod J. Rohrich Announces the Dates for 2016 Dallas Rhinoplasty Symposium 3Health News:Attorney from William Mattar Leads Discussion on Bicycle Accidents 2Health News:Dr. Jennifer Renee Hanes Named by First Choice Emergency Room as Medical Director of Missouri City, TX Facility 2Health News:Dr. Jennifer Renee Hanes Named by First Choice Emergency Room as Medical Director of Missouri City, TX Facility 3
... in people with diabetes than in those without the ... of Archives of Ophthalmology , one of the ... Americans had diagnosed diabetes mellitus in 2005 and another ... in the article. It is estimated that the number ...
... Oct. 13 As the first-ever report,by the United ... presented to Member States today, the Campaign to End,Fistula ... it serves.,According to its annual report, the campaign now ... in Africa, Asia and the Arab States. When it,was ...
... the Chargers Points to Myo-Med for Injury Recovery, ... Tomlinson points to Myo-Med ( http://www.myomed.com ) as,a key ... the Patriots,Tomlinson became the 17th player in NFL history ... times Sunday, a feat unexpected by critics who,thought his ...
... than Alzheimer,s patients, healthy controls , , MONDAY, Oct. 13 ... than healthy people or Alzheimer,s patients to have vitamin ... of Medicine in Atlanta. , They compared vitamin D ... 99 healthy people matched for age and other factors. ...
... N.J., Oct. 13, 2008 The AMERIGROUP Foundation,today ... for Children with,Hidden Intelligence (SCHI) to enhance the ... private school that specifically educates,multiply handicapped, underprivileged children ... is to try and alleviate the suffering of ...
... System, Supports Global Pharma Client in Closing ... CHESTER, Pa., Oct. 13 Modevity, LLC announced,today ... Imperium technology to become the primary platform for ... for their new product video content. Imperium is ...
Cached Medicine News:Health News:Vision loss more common in people with diabetes 2Health News:Campaign to End Fistula Quadruples In Size, Reaching Over 45 Countries, Says New Report 2Health News:Campaign to End Fistula Quadruples In Size, Reaching Over 45 Countries, Says New Report 3Health News:Tomlinson Attributes Rebound to Anti-Inflammatory Cream 2Health News:Parkinson's Patients More Prone to Vitamin D Deficiency 2Health News:AMERIGROUP Foundation Supports the School for Children with Hidden Intelligence 2Health News:Global Pharma Integrates Imperium(TM) to Support Launch Content ROI Initiatives! 2
(Date:7/3/2015)... , July 3, 2015 ... bekannt, vorbehaltlich bestimmter Abschlussbedingungen eine 100-prozentige Beteiligung ... zu haben. Mit dieser Übernahme dringt Lupin ... einem Umsatz von 765 Mrd. RUB im ... der Welt gehörte (IMS Health). Seit über ...
(Date:7/2/2015)... Pharma Major Lupin Limited ... en ZAO "Biocom" en Rusia bajo ciertas condiciones ... Lupin en el mercado farmacéutico de Rusia que ... como uno de los 10 principales mercados farmacéuticos ... de una década, el mercado farmacéutico ruso registró ...
(Date:7/2/2015)... VANCOUVER , July 2, 2015 /PRNewswire/ - ... today that its common shares have been approved for listing ... symbol "EPIX". ESSA will begin trading on NASDAQ ... on the TSX Venture Exchange under the symbol "EPI". ... shares on the NASDAQ, each of the Company,s outstanding special ...
Breaking Medicine Technology:Lupin übernimmt Biocom aus Russland 2Lupin übernimmt Biocom aus Russland 3Lupin adquiere Biocom en Rusia 2Lupin adquiere Biocom en Rusia 3ESSA Pharma Inc. to Commence Trading on the NASDAQ Capital Market 2ESSA Pharma Inc. to Commence Trading on the NASDAQ Capital Market 3ESSA Pharma Inc. to Commence Trading on the NASDAQ Capital Market 4
... N.Y., Nov. 16 Misonix, Inc. (Nasdaq: MSON ... technology, which in Europe is used for the ablation ... has entered into a new, three year distribution agreement ... the distribution of the SonaStar(TM) Ultrasonic Surgical Aspirator and ...
... , ... Corporation,(OTC Bulletin Board: CHME) ("China Medicine" or "the Company"), ... pharmaceuticals,traditional Chinese medicines (TCM), nutritional and dietary supplements, and,medical ... results. , , Third Quarter 2009 ...
Cached Medicine Technology:Misonix Announces New Distribution Agreement for Argentina 2Misonix Announces New Distribution Agreement for Argentina 3China Medicine Announces Strong Third Quarter 2009 Results 2China Medicine Announces Strong Third Quarter 2009 Results 3China Medicine Announces Strong Third Quarter 2009 Results 4China Medicine Announces Strong Third Quarter 2009 Results 5China Medicine Announces Strong Third Quarter 2009 Results 6China Medicine Announces Strong Third Quarter 2009 Results 7China Medicine Announces Strong Third Quarter 2009 Results 8China Medicine Announces Strong Third Quarter 2009 Results 9China Medicine Announces Strong Third Quarter 2009 Results 10China Medicine Announces Strong Third Quarter 2009 Results 11China Medicine Announces Strong Third Quarter 2009 Results 12China Medicine Announces Strong Third Quarter 2009 Results 13China Medicine Announces Strong Third Quarter 2009 Results 14China Medicine Announces Strong Third Quarter 2009 Results 15
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: