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

EXTON, Pa., Jan. 8 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today provided the following update on its petition to the U.S. Food and Drug Administration (FDA) regarding Vancocin(R) (vancomycin hydrochloride capsules).

As part of the company's continuing efforts to assure the safety of patients afflicted with Clostridium difficile infection, ViroPharma yesterday presented its views on the in vitro dissolution bioequivalence method proposed by OGD, as well as important related health and safety information, to officials in the FDA's Office of Pharmaceutical Sciences (OPS), Office of Generic Drugs (OGD) and FDA legal counsel. ViroPharma appreciates the FDA's time and attention to this matter.

Consistent with the eventual availability of the slides presented by ViroPharma at the meeting in the FDA Docket for ViroPharma's petition on this matter, ViroPharma has posted these slides to its corporate website (http://www.viropharma.com/OGDpetition/).

Additionally, the company notes that the FDA's website docket at times experiences a delay in making Citizens Petition and supplement submissions available for public review through the internet. In the interest of transparency, ViroPharma also has posted to its website the following supplement submissions previously filed by ViroPharma, but which are not yet available on the FDA's website:
-- December 2007 Docket submission by ViroPharma detailing how ViroPharma

believes the OGD's actions regarding Vancocin are illustrative of

larger systemic problems at the OGD, and amending the company's

petition to request that the FDA take appropriate additional cor
'/>"/>

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:7/9/2014)... for more than watching World Cup highlights, Brian Williams ... landing in unfortunate positions on railings. A University of ... Online Journal shows that YouTube also allows researchers, ... public on topics of skin cancer and prevention. , ... the future of how we communicate around the world," ...
(Date:7/9/2014)... Infectious Diseases (NIAID), part of the National Institutes ... of CRS3123, an investigational oral antibiotic intended to ... ) infection. CRS3123 (previously known as REP3123) is ... while sparing normal intestinal bacteria. , The Phase ... men and women ages 18 to 45 in ...
(Date:7/9/2014)... A retrospective study conducted by researchers at Tufts ... among adults with intellectual and developmental disabilities, the likelihood ... receiving dental care increased. The findings, published in the ... may help improve interventions designed to address the oral ... researchers reviewed the dental records of 107 patients at ...
(Date:7/9/2014)... older age with kidney and heart disease have raised ... older adults. However, in the first study to look ... of Medicine at the University of Pennsylvania report that ... life expectancy and cardiovascular health as very healthy older ... of the ever increasing organ transplant waitlists, the authors ...
(Date:7/9/2014)... published in the scientific journal Nature Neuroscience ... at Universit Laval, reveals that it is possible to ... rekindling pain so that it can subsequently be erased. ... chronic pain. , The researchers from the Faculty of ... mentale de Qubec (IUSMQ) were inspired by previous work ...
Breaking Medicine News(10 mins):Health News:Study of dermatology on YouTube shows new ways science reaches public 2Health News:NIH launches Phase I clinical trial of novel drug to treat Clostridium difficile infection 2Health News:Adults with special needs see gains, challenges with long term oral care 2Health News:Adults with special needs see gains, challenges with long term oral care 3Health News:Penn study finds living kidney donation does not increase risk of death or heart disease for older 2Health News:Discovery of a new means to erase pain 2
... a challenge for patients in the U.S. health care ... an updated paper released today. Racial and Ethnic ... a policy paper that was originally released in 2003, ... racial and ethnic minority patients and their white counterparts. ...
... bioGUNE and led by Dr. Aitor Hierro, have opened ... of neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), ... of the National Academy of Sciences of the ... possibility of research in humans to detect this pathology ...
... 2010 The Marilyn B. Gula Mountains of Hope ... a $50,000 donation to the Phoenix-based Translational Genomics Research ... of $300,000. In addition, the Mountains of Hope ... Hospitals (UH) Ireland Cancer Center, bringing the total donated ...
... during surgery for less complicated congenital heart defects ... neurocognitive abilities, such as intelligence, memory, motor skills ... Hospital of Philadelphia, in a study in the ... neuropsychological effects after surgery for acyanotic heart defects. ...
... School of Medicine have discovered that a kind of ... but not found in humans provokes a strong immune ... chronic inflammation is a major issue. This non-human ... drugs, and may be limiting or undermining their therapeutic ...
... , FRIDAY, July 23 (HealthDay News) -- As the nation ... Disabilities Act on Monday, a new survey finds that the ... of life for people with disabilities. Many social and ... disabilities and those without, according to a survey conducted by ...
Cached Medicine News:Health News:Disparities remain a challenge in health care says American College of Physicians 2Health News:New approach which can help to predict neurodegenerative diseases 2Health News:New approach which can help to predict neurodegenerative diseases 3Health News:The Marilyn B. Gula Mountains of Hope Foundation donates additional research funds to TGen 2Health News:Heart bypass for uncomplicated heart surgery does not reduce neurocognitive function in children 2Health News:Non-human sugar in biotech drugs causes inflammation 2Health News:Non-human sugar in biotech drugs causes inflammation 3Health News:Americans With Disabilities Act Reaches 20th Anniversary 2Health News:Americans With Disabilities Act Reaches 20th Anniversary 3Health News:Americans With Disabilities Act Reaches 20th Anniversary 4
(Date:1/15/2014)...  Humberto C. Antunes,  Galderma  worldwide CEO, will receive a ... of Drugs in Dermatology (JDD) at the upcoming ... is January 17-20, 2014, at the Omni Orlando Resort at ChampionsGate ... The ODAC is a distinguished event that delivers a ...
(Date:1/15/2014)... 15, 2014 MultiCell Technologies, Inc. (OTC Bulletin Board: ... patent application concerning composition of matter, biological targets, mechanism ... cell death.  This patent application describes ... RNA molecules (VSRNAs) which interfere with the basic homeostatic ...
(Date:1/15/2014)... , Jan. 15, 2014 Reportlinker.com ... is available in its catalogue: ... Drug Forecast and Market Analysis to 2022 ... PharmaPoint: Atopic Dermatitis - India Drug Forecast ...
Breaking Medicine Technology:Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 2Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 3Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 4MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 2PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 4PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 5
24-Well Slot Blot...
... Disposable, clear, APET plastic tray. Ideal for ... those trays used for multipurposes. Pour spouts ... A marker or label may be used ... trays on rockers or shakers for staining ...
... with vacuum stage, porous vacuum plate, reservoir seal ... The Model 785 vacuum blotter quickly and ... gel onto a nylon membrane. Because it generally ... acid samples can be separated on a gel, ...
... vacuum stage, porous vacuum plate, reservoir seal O-ring, ... The Model 785 vacuum blotter quickly and efficiently ... onto a nylon membrane. Because it generally requires ... samples can be separated on a gel, transferred ...
Medicine Products: