Navigation Links
ViroPharma Announces Approval of Modernized Labeling for Vancocin® (vancomycin hydrochloride, USP) Capsules
Date:12/14/2011

Parallel efforts regarding generic vancomycin capsules include ViroPharma's 2006 citizen petition, which has yet to be answered by FDA. Some recent issues raised in the petition include:

  • The work of Omar Vesga, M.D., of the Section of Infectious Diseases at University of Antioquia Medical School and Hospital Universitario San Vicente de Paul in Medellin, Colombia, substantiating the concerns of infectious disease experts that generic vancomycin capsules should not be approved without demonstrating in vivo efficacy.   Vesga showed generic intravenous vancomycin products, despite meeting all standard tests of generic equivalence, nonetheless fail in vivo (Generic Vancomycin Products Fail In Vivo despite Being Pharmaceutical Equivalents of the Innovator; Omar Vesga, et al.; Antimicrob. Agents Chemother. August 2010 vol. 54 no. 8 3271-3279).  This demonstration of generic inequivalence with the simple IV formulations of vancomycin supports the need to require that the more complicated generic vancomycin capsules demonstrate in vivo efficacy.
  • The United States Pharmacopeia (USP) agrees with ViroPharma that a modern assay to measure vancomycin capsule dissolution is needed: (http://www.usp.org/USPNF/notices/modernizationofMicrobialAssayProcedures.html).   ViroPharma has explained how without such an assay, FDA's proposed in vitro bioequivalence method for generic vancomycin capsules is unworkable, thus preventing the approval of generic vancomycin capsules.
  • FDA Advisory Committee experts emphasized the need for particularly rigorous inspections and cGMP compliance for generic vancomycin capsules approved via FDA's in vitro method. (ViroPharma Incorporated Letter to FDA in re: August 4 meeting of FDA Advisory Committee, Docket No. FDA-2009-N-0664-0047 (Oct 6, 2009)). Vesga's
    '/>"/>

SOURCE ViroPharma Incorporated
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. ViroPharma to Present at Three Upcoming Healthcare Conferences
2. ViroPharma to Present at the Natixis Bleichroeder Conference
3. ViroPharma To Present at the Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
4. ViroPharma to Release 2008 First Quarter Financial Results on April 30, 2008
5. ViroPharma Announces Discontinuation of HCV-796 Development
6. ViroPharma Announces Completion of Enrollment in Phase 3 Study of Maribavir in Stem Cell Transplant Patients
7. ViroPharma Incorporated Completes Acquisition of Lev Pharmaceuticals
8. ViroPharma Announces Presentation of Cinryze(TM) Data in Acute Treatment of Hereditary Angioedema
9. ViroPharma Announces Discontinuation of Maribavir Phase 3 Study in Liver Transplant Patients
10. ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
11. ViroPharma Incorporated Reports Third Quarter 2009 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)...  CryoLife, Inc. (NYSE: CRY ), a ... cardiac and vascular surgery, announced today that James ... has been elected to the Company,s Board of Directors, ... Anderson , Executive Chairman of CryoLife, stated, "Since joining the ... excellent leader who is well positioned to maximize CryoLife,s ...
(Date:10/22/2014)... LOUIS , Oct. 21, 2014  Early ... often subtle or unnoticed, but new technology, coupled ... outcomes and leading to earlier detection of eye ... affects 29 million Americans. If left untreated, these ... even blindness. Recently, optometric researchers ...
(Date:10/22/2014)... InVivo Therapeutics Holdings Corp. (OTCQB: NVIV) based ... spinal cord injury (SCI) treatment with their novel Neuro-Spinal ... tissue regrowth in the spinal cord area when cells ... approved polymer, the scaffold ultimately breaks down to water ... body. NVIV has recently attracted significant investor attention with ...
Breaking Medicine Technology:Pat Mackin Joins CryoLife Board of Directors 2Pat Mackin Joins CryoLife Board of Directors 3Technology Advancements Enhance Early Detection of Eye Diseases Associated with Diabetes 2Technology Advancements Enhance Early Detection of Eye Diseases Associated with Diabetes 3InVivo Therapeutics Analyst Coverage Initiated: Analyst Report by BrokerBank Securities, Inc. 2InVivo Therapeutics Analyst Coverage Initiated: Analyst Report by BrokerBank Securities, Inc. 3
... MedPro Imaging, a premium provider ... the expansion of its operations with the opening ... in Longmont, Colo.  The 5,000-square foot facility features ... U.S. market, offering high quality computer-based transducer repair ...
... Botanic Pharmaceutical Inc. (NYSE AMEX: CBP ) ... distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines ... successfully completed a feasibility study to analyze the benefits ... production operations. As a result of the study, the ...
Cached Medicine Technology:MedPro Imaging Expands Operations With Opening of Dedicated Advanced Transducer Repair Facility 2MedPro Imaging Expands Operations With Opening of Dedicated Advanced Transducer Repair Facility 3China Botanic Pharmaceutical Announces Plans to Switch to Renewable Bio-Fuel - Straw Pellets 2China Botanic Pharmaceutical Announces Plans to Switch to Renewable Bio-Fuel - Straw Pellets 3
(Date:10/25/2014)... York (PRWEB) October 25, 2014 ... lawsuits ( http://www.vaginalmeshlawsuit2015.com/ ) filed against Boston ... in U.S. District Court, Southern District of West ... Judgment on Punitive Damages in a group of ... a ruling issued on October 21st, U.S. District ...
(Date:10/25/2014)... supply to an arm or a leg before heart surgery ... to a new study. "During heart surgery we ... be able to operate on it. After some time without ... energy because it doesn,t get oxygen. When we shut off ... arm or a leg, the body prepares for an upcoming ...
(Date:10/25/2014)... (HealthDay News) -- Researchers who discovered antibiotics in ... cause for concern. The use of antibiotics ... human consumption contribute to the development of antibiotic-resistant ... information from the study. Each year in ... million people and kill about 23,000, according to ...
(Date:10/25/2014)... Randy Dotinga HealthDay Reporter ... tests are developed that spot increased risks for certain cancers, ... about getting screened. But a new study suggests that, ... People who found out their genes doubled their risk of ... risk to get screened. "It didn,t make any difference, ...
(Date:10/22/2014)... (PRWEB) October 22, 2014 On Saturday, October ... its fourth annual family health and fitness fair ¡Vive tu ... physical activity and good nutrition for better health and wellness ... which is free and open to the public, will be ... Brownsville, from 9:00 am to 1:00 pm. , “¡Vive ...
Breaking Medicine News(10 mins):Health News:Transvaginal Mesh Lawsuits Move Forward, As Federal Judge Denies Motion for Summary Judgment on Punitive Damages in Florida Cases, Bernstein Liebhard LLP Reports 2Health News:Transvaginal Mesh Lawsuits Move Forward, As Federal Judge Denies Motion for Summary Judgment on Punitive Damages in Florida Cases, Bernstein Liebhard LLP Reports 3Health News:Transvaginal Mesh Lawsuits Move Forward, As Federal Judge Denies Motion for Summary Judgment on Punitive Damages in Florida Cases, Bernstein Liebhard LLP Reports 4Health News:Brief Interruption of Blood Supply to Limb Might Aid Heart Surgery: Study 2Health News:Researchers Say Antibiotics in Fish a Health Concern 2Health News:Knowing Genetic Risk for Cancer May Not Change Behavior 2Health News:Brownsville Community Health Center Presents Fourth Annual ¡Vive Tu Vida! Get Up! Get Moving!® Event 2Health News:Brownsville Community Health Center Presents Fourth Annual ¡Vive Tu Vida! Get Up! Get Moving!® Event 3Health News:Brownsville Community Health Center Presents Fourth Annual ¡Vive Tu Vida! Get Up! Get Moving!® Event 4
... effective treatments for cancer patients, it is essential to ... the disease. A team of scientists from the ... system which aims to pinpoint potential "biomarkers" of early ... at the structures of specific sugar molecules which are ...
... Staffers from West Jefferson Medical Center and East Jefferson ... St. Luke,s Hospital, CEDAR RAPIDS, Iowa, July 9 ... hospitals that operated,during Hurricane Katrina will caravan to Iowa ... by the Iowa Flood of 2008., Nicknamed, "Big ...
... WASHINGTON, July 9 The following is a,statement ... "Today the American Medical Association celebrates that ... and voted to stop Medicare,physician payment cuts that ... a,bipartisan, veto-proof majority of 69 to 30. We ...
... The Pharmaceutical Care,Management Association (PCMA) released the ... which includes a provision that requires,physicians to use ... of an e-prescribing requirement in Medicare is a ... e-prescribing,is the most important issue in the Medicare ...
... 9 Exponent, Inc.,(Nasdaq: EXPO ), today announced ... ended June 27, 2008, immediately following the close of,the ... host a,corresponding conference call and live webcast at 4:30 ... and Chief Executive,Officer, and Richard Schlenker, Chief Financial Officer, ...
... A lawsuit charges,pharmaceutical giant Pfizer was motivated by ... potentially deadly side-effects associated with its popular,smoking cessation ... name,Chantix. The suit, brought by the widow of ... using Chantix as prescribed. The victim,s,tragic death occurred ...
Cached Medicine News:Health News:A short and sweet diagnosis for cancer? 2Health News:'Big Relief From the Big Easy' Headed to Cedar Rapids Hospital 2Health News:Chantix Blamed for Suicide in Lawsuit Against Pfizer Filed by Cory Watson Crowder & DeGaris 2
This is long known for its purity and mildness, Castile Soap is also an effective cleaning agent that is used in a variety of applications. It rinses clean while leaving the skin soft and healthy....
... This antimicrobial skin cleanser will not leave ... with frequent washings. With persistent Antimicrobial action, ... of microorganisms, including gram-negative and gram-positive bacteria, ... as a 15 second hand wash. The ...
... Protectant Prep Pads prepares the skin for ... When dry, it leaves a thin film ... clean surface and a barrier for natural ... of a dressing or tape. Skin Protectant ...
... Povidone Iodine Prep Pads ... surface pathogens including bacteria, ... yeast. Povidone Iodine is ... wounds or mucus membranes. ...
Medicine Products: