Navigation Links
ViroPharma Provides Update on Vancocin(R)
Date:12/15/2008

EXTON, Pa., Dec. 15 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today provided the following update regarding Vancocin(R) (vancomycin hydrochloride capsules).

The Food and Drug Administration (FDA) has posted draft guidance for establishing bioequivalence (BE) to Vancocin. The new draft guidance is open for public comment, and if finalized as proposed would add new requirements for generic applicants beyond the in vitro dissolution testing originally proposed in March 2006. Under the draft guidance, generic applicants will also have to show that their products contain substantially the same inactive ingredients in substantially the same quantities as Vancocin. For generic versions of Vancocin that are not Ql and Q2 the same as Vancocin with respect to inactive ingredients, FDA is recommending in vivo BE studies with clinical endpoints in patients with Clostridium difficile.

Importantly, FDA has also called for public process specific to Vancocin, announcing that there will be a 60 day public comment period to review and comment on these draft guidance. FDA has acknowledged the complexity of the issues involved, and specifically stated that they will carefully consider such comments before responding to ViroPharma's Citizen Petition and finalizing BE recommendation for Vancocin.

Nowhere in the draft guidance does it indicate that FDA has correlated the described in vitro tests to an in vivo outcome, as required by FDA's regulation. A detailed description of this topic can be found at the following link (please cut and paste into your browser):

http://www.regulations.gov/fdmspublic/component/main?main=Document
'/>"/>

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

Page: 1 2 3 4

Related medicine news :

1. ViroPharma to Present at the Maxim Group First Annual Growth Conference
2. ViroPharma to Present at the UBS Global Life Sciences Conference
3. ViroPharma Incorporated Reports Third Quarter and Nine-Month 2007 Financial Results
4. ViroPharma Receives European Orphan Drug Designation for CAMVIA(TM)
5. ViroPharma to Present at the 26th Annual JP Morgan Healthcare Conference
6. ViroPharma Augments Senior Management
7. ViroPharma Provides Update on Vancocin(R)
8. Vincent J. Milano to Succeed Michel de Rosen as President and Chief Executive Officer of ViroPharma
9. ViroPharma Incorporated Reports Fourth Quarter and Full Year 2007 Financial Results
10. ViroPharma Incorporated Reports First Quarter 2008 Financial Results
11. ViroPharma to Release 2008 Second Quarter Financial Results on July 30, 2008
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/1/2014)... October 01, 2014 Two bicyclists began ... them across the country in an effort to raise ... families. The cyclists, a father-daughter team, plan to ... in Blaine, Washington and finishing in Key West Florida. ... For The Warriors®, a national nonprofit organization that assists ...
(Date:10/1/2014)... Long-acting insulin is safer and more effective than ... according to new research published in the ... and twice-daily doses of both long- and intermediate-acting ... , "In patients with Type 1 diabetes, we ... insulin when it came to controlling blood sugar, ...
(Date:10/1/2014)... (PRWEB) October 01, 2014 Indosoft, Inc., a ... Q-Suite, announces that it has added support for Sangoma ... Sangoma and Indosoft have a history of bringing ... Sangoma's patent-pending technology offers a significant benefit to those using ... that is now available to users of Q-Suite. , In ...
(Date:10/1/2014)... October 01, 2014 Nearly a year-and-a-half ... Pueblo County District Court jury awarded him $4.75 million; ... 61 years old. Casper had been too sick ... , According to the Court Documents (District Court, Pueblo ... BPH, a benign non-cancerous condition of his prostate, when ...
(Date:9/30/2014)... Thompson HealthDay Reporter TUESDAY, ... of Ebola has surfaced in the United States, involving a ... announced late Tuesday. The critically ill patient, being cared ... been diagnosed with the deadly virus, officials from the U.S. ... afternoon news conference. The man is receiving intensive care ...
Breaking Medicine News(10 mins):Health News:Father-Daughter Cycling Duo to Ride Cross-Country to Benefit Hope For The Warriors 2Health News:Long-acting insulin is safer, more effective for patients with Type 1 diabetes 2Health News:Indosoft Announces Q-Suite Support For Sangoma Lyra 2Health News:Law Offices of D.R. Jones Client Wins 4.7 Million Dollar Verdict, Insurance Company Files Motion for a New Trial 2Health News:Law Offices of D.R. Jones Client Wins 4.7 Million Dollar Verdict, Insurance Company Files Motion for a New Trial 3Health News:CDC Confirms First Patient Diagnosed With Ebola in United States 2Health News:CDC Confirms First Patient Diagnosed With Ebola in United States 3
... ... helicopter, DENVER, Oct. 27 ... in the,world, today announced its Products Division has been awarded a contract ... Black Hawk Multi-Mission Medevac Interior Systems. Production has,started and is anticipated to ...
... Journal of Neurodevelopmental Disorders to complement its ... will be available in both online and print ... include both researchers and clinicians interested in an ... of neurodevelopmental disorders. , The Journal of ...
... people who have a positive outlook, lower stress levels, ... income and no chronic health conditions are more likely ... study in the October issue of The ... study of its kind, researchers from Portland State University, ...
... added benefits to improve care and quality ... health conditions-, SAN ANTONIO, Texas, Oct. 27 ... period which begins November 15th, Care,Improvement Plus today ... Plan,(SNP) offerings for chronically ill Medicare beneficiaries in ...
... the Johns Hopkins Bloomberg School of Public Health have ... older Americans to understand patterns of disability and aging. ... National Institutes of Health, is expected to award approximately ... and implement the new survey. The study will include ...
... PHILADELPHIA Edith P. Mitchell, M.D., clinical professor, Department ... Jefferson University and associate director of Diversity Programs for ... with a ,Tree of Life, award from The Wellness ... organization. , The Tree of Life award ...
Cached Medicine News:Health News:Air Methods Receives $17 Million Contract from Sikorsky Aircraft Company 2Health News:Springer adds Journal of Neurodevelopmental Disorders to biomedical journal portfolio 2Health News:Study reveals factors of exceptional health in old age 2Health News:Care Improvement Plus Launches 2009 Benefits in Texas 2Health News:Bloomberg School of Public Health to lead nationwide aging study 2Health News:Jefferson doctor receives Tree of Life award 2Health News:Jefferson doctor receives Tree of Life award 3
(Date:9/30/2014)... 2014 The Chinese wound care market is ... in the incidence of lifestyle diseases, coupled with the ... of better quality of wound care products provide the ... of public health insurance schemes and increased reimbursement rate ... on the findings of primary and secondary researches, this ...
(Date:9/30/2014)... BRUNSWICK, N.J., Sept. 30, 2014 The ... Kessler Foundation and New Jersey Health Foundation (NJHF) ... and patient care programs has been announced by ... officer of Kessler Foundation and James M. ... "The experience of New Jersey Health ...
(Date:9/30/2014)... Calif. , Sept. 30, 2014 ... of the American Association of Tissue Banks (AATB), ... , Chief Executive Officer. Accreditation follows ... by a specially trained AATB inspector.  It establishes ... performance within the facility meets or exceeds the ...
Breaking Medicine Technology:China Wound Care Market 2China Wound Care Market 3Kessler Foundation Partners with New Jersey Health Foundation To Start Innovative Companies To Change the Lives of People with Disabilities 2Biostructures, LLC Earns AATB Accreditation 2
... 2007 - Late-breaking Phase III,clinical trial data ... Thrombosis and Haemostasis (ISTH) Congress demonstrate,that once-daily ... venous thromboembolism (VTE) in patients undergoing,knee replacement ... current standard of care. Patients in the ...
... with Positive Phase IIa Clinical,Trial Results, First ... Key,Product in AM-Pharma's Pipeline , BUNNIK, The ... developing novel therapeutics to treat,infectious and inflammatory ... its Phase IIa Alkaline Phosphatase (AP) trial,for ...
Cached Medicine Technology:Phase III Trial Results Show Superiority of Rivaroxaban over,Enoxaparin for the Prevention of Venous Thromboembolism in Patients,Undergoing Knee Replacement Surgery 2Phase III Trial Results Show Superiority of Rivaroxaban over,Enoxaparin for the Prevention of Venous Thromboembolism in Patients,Undergoing Knee Replacement Surgery 3Phase III Trial Results Show Superiority of Rivaroxaban over,Enoxaparin for the Prevention of Venous Thromboembolism in Patients,Undergoing Knee Replacement Surgery 4Phase III Trial Results Show Superiority of Rivaroxaban over,Enoxaparin for the Prevention of Venous Thromboembolism in Patients,Undergoing Knee Replacement Surgery 5AM-Pharma Announces Positive Results of Phase IIa Clinical Trial,with Alkaline Phosphatase For Ulcerative Colitis 2AM-Pharma Announces Positive Results of Phase IIa Clinical Trial,with Alkaline Phosphatase For Ulcerative Colitis 3AM-Pharma Announces Positive Results of Phase IIa Clinical Trial,with Alkaline Phosphatase For Ulcerative Colitis 4AM-Pharma Announces Positive Results of Phase IIa Clinical Trial,with Alkaline Phosphatase For Ulcerative Colitis 5
Latex agglutination slide test for the qualitative and semi-quantitative in vitro determination of CRP in serum....
For the quantitative in vitro determination of Apolipoprotein A-1 in human serum....
For the quantitative determination of apolipoprotein B (apo B) in serum and plasma....
The GGT method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of g-glutamyl transferase activity in serum and plasma...
Medicine Products: