Navigation Links
ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
Date:3/18/2009

o the point of ignoring the cautionary statements contained in the very authority cited by OGD as scientific support for its method, as well as the advice of its own experts.
  • When faced with a safety issue identified in Vancocin's labeling and by its own 2008 advisory committee - the potential for systemic absorption of the drug at toxic levels and the need for pharmacokinetic (PK) testing to address that safety issue - OGD again turned away from patients with CDI. Instead, they concluded that PK testing is unnecessary because the drug is not absorbed in healthy patients who are not infected with CDI.
  • By focusing exclusively on the lower GI tract, the December 2008 Draft Guidance fails to account for another indicated use of Vancocin - Staphylococcus aureus GI infections - which occur in both the upper and lower GI tract.
  • OGD's Q1Q2 sameness standard is flawed and incomplete. OGD acknowledges that inactive ingredients may affect product performance, and that the state of knowledge in this area is underdeveloped. However, OGD proposes without explanation that a Q1Q2 standard developed for oral solutions will nonetheless apply to Vancocin, an oral capsule product. Then, OGD backs off the sameness supposedly ensured by the Q1Q2 standard, and permits generic applicants to vary their inactive ingredients in the absence of any standards to evaluate the effect of such variations on the generic product's performance.
  • "OGD's extensive litany of errors and omissions not only required an equally extensive response, but should cause many to question, as we do, whether OGD has abrogated its decision-making role in bioequivalence method development for Vancocin," continued Doyle.

    While ViroPharma's comments note that numerous flaws prevent use of OGD's proposed new BE method for Vancocin, ViroPharma also believes that, even if the new method was valid, OGD's a
    '/>"/>

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

    Page: 1 2 3 4 5 6 7

    Related medicine technology :

    1. ViroPharma Announces Discontinuation of Maribavir Phase 3 Study in Liver Transplant Patients
    2. ViroPharma Announces Presentation of Cinryze(TM) Data in Acute Treatment of Hereditary Angioedema
    3. ViroPharma Incorporated Completes Acquisition of Lev Pharmaceuticals
    4. ViroPharma Announces Completion of Enrollment in Phase 3 Study of Maribavir in Stem Cell Transplant Patients
    5. ViroPharma Announces Discontinuation of HCV-796 Development
    6. ViroPharma to Release 2008 First Quarter Financial Results on April 30, 2008
    7. ViroPharma To Present at the Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
    8. ViroPharma to Present at the Natixis Bleichroeder Conference
    9. ViroPharma to Present at Three Upcoming Healthcare Conferences
    10. Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration
    11. Boston Scientific Submits Final Modules to FDA for Approval of Second-Generation Small Vessel and Long Lesion Stents
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:3/27/2015)... - Russell Williams , President of ... 2015-2016 Quebec Budget, noting the fiscal discipline and the ... However, the association is concerned about the decline of ... intent to strive for a balanced budget this year, ... Quebec,s economic development is encouraging," said Mr. ...
    (Date:3/27/2015)... Vein & Surgery Clinic is the only clinic offering laser ... Victoria, Texas . The clinic specializes in the ... for a variety of medical and cosmetic conditions. High-end vein ... for their patients. Since adding laser tattoo removal, Victoria Vein ... residents get rid of their unwanted ink. "Our ...
    (Date:3/27/2015)... A new report from Kalorama Information says that other countries ... Chile , Colombia and ... The healthcare research firm said that while Brazil ... American continent with a population of over 200 million people ... country,s regional economic clout does not necessarily ensure its status ...
    Breaking Medicine Technology:Quebec 2015-2016 Budget: Rx&D welcomes fiscal discipline and biopharma working group, but the decrease in government spending on medicines is questioned 2Quebec 2015-2016 Budget: Rx&D welcomes fiscal discipline and biopharma working group, but the decrease in government spending on medicines is questioned 3Victoria Vein And Surgery Clinic Uses Advanced Astanza Duality Tattoo Removal Technology 2Kalorama: Beyond Brazil, Latin American IVD Market Grows 2Kalorama: Beyond Brazil, Latin American IVD Market Grows 3Kalorama: Beyond Brazil, Latin American IVD Market Grows 4
    ... at,European Cystic Fibrosis Society Annual,Meeting. ... ... -- Exocrine pancreatic insufficiency (EPI) is a,deficiency of digestive , , ... of diseases, including cystic,fibrosis, chronic pancreatitis, and , , ...
    ... 8, 2007 - IMPAX Laboratories,Inc. (OTC:IPXL) today ... compound, IPX054, a combined immediate-,and extended-release carbidopa/levodopa ... presented at the Movement Disorder,Society's 11th International ... Istanbul, Turkey on June 7, 2007. The ...
    Cached Medicine Technology:Eurand to Present Zentase Phase III Data 2Eurand to Present Zentase Phase III Data 3IMPAX Presents at Movement Disorder Society's 11th International,Congress of Parkinson's Disease and Movement Disorders 2IMPAX Presents at Movement Disorder Society's 11th International,Congress of Parkinson's Disease and Movement Disorders 3IMPAX Presents at Movement Disorder Society's 11th International,Congress of Parkinson's Disease and Movement Disorders 4
    (Date:3/28/2015)... Orlando, FL (PRWEB) March 28, 2015 ... pre-existing conditions coverage is made available to all visitors ... States, effective immediately. All members are encouraged to purchase ... finalized to avoid lack of proper coverage for pre-existing ... suffer from one or two medical conditions with serious ...
    (Date:3/28/2015)... March 28, 2015 How best to ... growing field in orthopaedic medicine. While diagnostic hip injections ... confirm the pain etiology, research presented today at the ... Specialty Day suggests that pain relief from this diagnostic ... surgery. , “Our study looked to assess if ...
    (Date:3/28/2015)... March 28, 2015 Lately the ... regarding recent changes and proposals around the NCAA. In ... and former collegiate student-athletes across a spectrum of universities ... on common challenges. The special panel consists of athletes ... sports ranging from football, track and field, baseball, and ...
    (Date:3/28/2015)... (PRWEB) March 28, 2015 ARDX will sponsor ... from 12pm -3pm at the Chesapeake Conference Center in Chesapeake, ... sponsoring an empowering event for women in the Hampton Roads ... the Stories of Women’s Lives. Women grow stronger through ... each other. This year the WWC™ theme is T-talk ...
    (Date:3/27/2015)... (PRWEB) March 27, 2015 Wellness for ... and business criteria for the spa and wellness industry–has ... clients who have experienced or are living with cancer. ... Spafinder Wellness 365® Network, will be identified with a ... as a provider of safe, therapeutic services for cancer ...
    Breaking Medicine News(10 mins):Health News:India Network Health Insurance Today Announces New Eligibility Criteria for Pre-existing Condition Health Insurance Coverage for Visitors to the United States 2Health News:India Network Health Insurance Today Announces New Eligibility Criteria for Pre-existing Condition Health Insurance Coverage for Visitors to the United States 3Health News:Pain Injections for Hip Arthroscopy Patients May Not Predict Surgical Outcomes 2Health News:SCI TV Panel of Former College Athletes Discusses Student Athlete Experience 2Health News:SCI TV Panel of Former College Athletes Discusses Student Athlete Experience 3Health News:Hands On HealthCare Massage Therapy & Wellness Day Spa Certified as “Cancer Aware” by Wellness for Cancer and Recognized on Spafinder.com 2Health News:Hands On HealthCare Massage Therapy & Wellness Day Spa Certified as “Cancer Aware” by Wellness for Cancer and Recognized on Spafinder.com 3Health News:Hands On HealthCare Massage Therapy & Wellness Day Spa Certified as “Cancer Aware” by Wellness for Cancer and Recognized on Spafinder.com 4
    ... kids to want to wash their handsDALLAS, May 12 ... virus from not washing their hands enough finally have some ... getting sick too often thought the reason might be that ... to SOAPRISE by Soap Labs LLC, a unique device that ...
    ... 3rd Party Wii(TM) Fitness Title and All-New Portable Nintendo ... 12 This Fall, gamers will be able to ... whether at home or on the go. Majesco Entertainment ... of video games for the mass market, and executive ...
    ... 12 NeuroScience, Inc. has launched NeuroSLP, a ... the hormones and neurotransmitters that regulate sleep. This ... informed decisions regarding patient care. The NeuroSLP protocol ... practitioners approach sleep difficulties. The system combines cutting ...
    ... study by a Ben-Gurion University of the Negev (BGU) ... mortality rates, with those who report impaired appetite more ... the May issue of the Journal of Nutrition, ... Daily Activity Energy Expenditure (DAEE-- an accurate measurement of ...
    ... Health Workforce BERKELEY, Calif. and OAKLAND, Calif., May 12 ... announced today the Kaiser Permanente Community Health Scholars Program, an ... educated public health workers. Funded by a $5 million grant ... the East Bay Community Foundation, the program - to be ...
    ... Help Plan Members Better Manage Healthcare Needs and Spending , ... Life Insurance Company of America (Guardian), one of the largest ... voluntary benefits for small and mid-sized companies, today introduced enhanced ... their employees will now have access to a broad range ...
    Cached Medicine News:Health News:Flashing Lights Help Kids Avoid the Swine Flu 2Health News:Majesco Entertainment and Interactive Game Group Announce Two New Jillian Michaels Fitness Video Games 2Health News:Majesco Entertainment and Interactive Game Group Announce Two New Jillian Michaels Fitness Video Games 3Health News:Majesco Entertainment and Interactive Game Group Announce Two New Jillian Michaels Fitness Video Games 4Health News:Majesco Entertainment and Interactive Game Group Announce Two New Jillian Michaels Fitness Video Games 5Health News:New System for Managing Sleep Disorders Aims to Improve Sleep Through Brain Chemistry 2Health News:Ben-Gurion U of the Negev study demonstrates link between appetite and elderly mortality 2Health News:UC Berkeley Launches Kaiser Permanente Community Health Scholars Program 2Health News:UC Berkeley Launches Kaiser Permanente Community Health Scholars Program 3Health News:Guardian Enhances Medical Plans With New Wellness Benefits 2Health News:Guardian Enhances Medical Plans With New Wellness Benefits 3Health News:Guardian Enhances Medical Plans With New Wellness Benefits 4
    ... The SEA 2000 Electrophoresis Apparatus (patented) provides ... DNA and RNA electrophoresis., In combination with ... 2000 covers applications that require a regular ... system., With the SEA 2000 it is ...
    ... Submerged horizontal gels offer many advantages ... a primary tool for the molecular biologist. ... readily dissipate heat. These gels allow sample ... by wicks or sample well dehydration. Horizontal ...
    ... The Mini-Sub cell GT system for ... acids in agarose gels includes a ... electrodes, a 7 x 7 cm ... two casting gates, and two 1.5 ...
    ... The DryEase Mini-Gel Drying System is a simple ... evaporation. The kit allows gels to be assembled ... both outer surfaces of the gels are exposed ... is minimized. The proprietary Gel-Dry™ Drying Solution modulates ...
    Medicine Products: