Navigation Links
FDA Pulls One Generic Form of Wellbutrin Off the Market
Date:12/5/2012

n of bupropion XL was only between 77 and 96 percent of the level of Wellbutrin.

The difference in blood concentration between Wellbutrin and bupropion in this study could explain the clinical difference in safety and effectiveness, Preskorn said. "If the concentration is substantially lower or higher, then your concern would be reduced efficacy or greater likelihood of off-target effects," he said.

Although it is unclear why only the generic XL in 300-mg tablets and not in 150-mg tablets, or only the Impax/Teva version of the 300-mg tablets, would lack bioequivalence, it could be because higher doses of the drug have trouble dissolving in the gastrointestinal tract, Preskorn said.

The FDA approved the generic versions of Wellbutrin XL based on the studies demonstrating bioequivalence at the lower, 150-mg dose.

Typically the FDA recommends that makers of generic drugs test the blood concentration of the drug at the highest dose and then extrapolate bioequivalence data for the lower doses based on these findings.

However, in the case of bupropion, the FDA granted a waiver to companies to test the lower dose because of concern that the higher dose could cause seizures in the volunteers, Walsh wrote.

Either way, extrapolating information about safety and efficacy from one dose is usually appropriate, said Dr. Sidney Wolfe, director of the health research group at Public Citizen, a nonprofit consumer advocacy organization based in Washington, D.C.

"For most drugs, there is such a wide difference between the amount that works and the amount that causes trouble that checking out every single dose is not necessary," he said.

However bupropion might be an exception. Ever since it entered the market in 1985, it was known there was a fine line between antidepressant effect and seizure risk, Wolfe said. The FDA knows which drugs have this type of narrow therapeutic window, and for them it might have been better to check out
'/>"/>

Copyright©2012 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3 4

Related medicine news :

1. Toward competitive generic drug prices in Canada
2. Generic drugs key to US overseas HIV relief
3. FDA Approves Generic Versions of Plavix
4. Plavixs New Generic Status Could Be Boon for Patients
5. Internet Speaker, Founder, and President of RevenFlo Web Team, Jason Broadwater, Discusses the Most Essential Marketing Tool Available for Effective Internet Marketing
6. Research: NCAA football exploits players in invisible labor market
7. Sun monitor set to go on the market
8. Stimulant marketed as natural in sports supplement actually of synthetic origin
9. Standard Process Inc.’s Marketing Team Wins Six Awards
10. As New Premature Ejaculation Drugs Get Closer To The Public Market, LastLonger2Night.com Announces A Drug-Free Solution
11. Content Writing King Announces Cancellation Of Experimental Video Creation Process For Their Article Marketing Website
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Pulls One Generic Form of Wellbutrin Off the Market
(Date:7/29/2014)... 29, 2014 Winter is here down ... afternoon in Sydney’s central business district. That is, until ... costume transformed the otherwise ordinary day into a celebration—a ... are ardent advocates of The Truth About Drugs, a ... Scientology . They woke up the city with a ...
(Date:7/29/2014)... DailyGossip.org reveals in its latest review that the new method ... patients and what they have to go through when cold ... of the new program. Ellie claims that she suffered from ... her very own research. Four years passed until she reached ... Get Rid of Cold Sores program claims that she was ...
(Date:7/29/2014)... Regardless of the good things that happen ... share those with. Love is about understanding, commitment and ... is also about overcoming all the challenges that a ... relationship, women need to know how to understand guys. ... program, please visit the official website at http://www.dailygossip.org/enchant-him-review-7111 ...
(Date:7/29/2014)... July 29, 2014 (HealthDay News) -- Want young children ... them something that,s healthy is good for them. Doing ... good, a new study suggests. "Parents and caregivers ... may be better off simply serving the food without ... yummy the food actually is," said study authors Michal ...
(Date:7/29/2014)... Advertising claims for cosmetic procedures using stem cells ... safety and effectiveness, according to a review in the ... , the official medical journal of the ... cells offer tremendous potential, but the marketplace is saturated ... patients at risk," write Dr Michael T. Longaker of ...
Breaking Medicine News(10 mins):Health News:Sydney Business District “Rocked” by The Truth About Drugs 2Health News:Get Rid of Cold Sores Fast Review Exposes the Way to Stop Outbreaks 2Health News:How to Reach the Heart of the Perfect Guy with "Enchant Him Program" - a Report by Daily Gossip Magazine 2Health News:Kids Will Pass on 'Healthy' Foods 2Health News:Beware of claims about cosmetic stem cells procedures, says review in Plastic and Reconstructive Surgery 2
... ... Hopkins Medical Institutions, the Karolinska University Hospital and Institute, and The Feinstein Institute for ... ... 10, 2010 -- An experimental thyroid drug reduces cholesterol without the troublesome side effects ...
... TUCSON, Ariz. , March 10 If ... of continuing medical education (CME) used by physicians will be ... dramatic increase over the 9% of CME delivered via the ... the winter, 2010 issue of the Journal of Continuing ...
... ... Registered Dietitian Day on March 10, the team behind Skinny in ... combining the best diet and nutrition information with the latest fashion ... ) online directory. Spearheaded by celebrity dietitian Tanya Zuckerbrot, M.S., ...
... ... ... -- A week from today, the Boston branch of the Harvard Business School Alumni ... co-founder Mike “Zappy” Zapolin will be in attendance to present the new website’s business ...
... ... ... ... ...
... may be able to safely lower the platelet ... patients without risking increased bleeding, according to new ... other medical institutions. Reducing platelet transfusions, and ... could help address frequent shortages in platelet supplies, ...
Cached Medicine News:Health News:Thyroid Hormone Analogue for Treating High Cholesterol 2Health News:Thyroid Hormone Analogue for Treating High Cholesterol 3Health News:Study Predicts Half of Physician Continuing Education Will Be Online by 2016 2Health News:New Interactive Dietitian Directory Launches on National Registered Dietitian Day: TheSkinnyonDietitians.com 2Health News:New Interactive Dietitian Directory Launches on National Registered Dietitian Day: TheSkinnyonDietitians.com 3Health News:New Interactive Dietitian Directory Launches on National Registered Dietitian Day: TheSkinnyonDietitians.com 4Health News:PrescriptionDrugs.com and Mike “Zappy” Zapolin Have Been Selected to Compete in Harvard Business School New Venture Contest 2Health News:PrescriptionDrugs.com and Mike “Zappy” Zapolin Have Been Selected to Compete in Harvard Business School New Venture Contest 3Health News:Zimmer Receives Recognition for Health Economics Data Presented at 77th Annual American Academy of Orthopaedic Surgeons Meeting 2Health News:Zimmer Receives Recognition for Health Economics Data Presented at 77th Annual American Academy of Orthopaedic Surgeons Meeting 3Health News:Zimmer Receives Recognition for Health Economics Data Presented at 77th Annual American Academy of Orthopaedic Surgeons Meeting 4Health News:Zimmer Receives Recognition for Health Economics Data Presented at 77th Annual American Academy of Orthopaedic Surgeons Meeting 5Health News:Fewer platelets could be used for some cancer and bone-marrow transplantation patients 2
(Date:7/29/2014)... -- Sequenom, Inc. (NASDAQ: SQNM ), a life ... total revenues of $39.8 million for the second quarter ... of $24.5 million for the second quarter of 2013. ... sold on May 30, 2014, has been accounted for ... been excluded from continuing operations for all periods. ...
(Date:7/29/2014)... GLENWOOD, Ill. , July 29, 2014  Landauer, ... in personal and environmental radiation measurement and monitoring, outsourced ... will release financial results for the fiscal third quarter ... 2014. The Company will host a ... at 9:00 a.m. Central Time (10 a.m. Eastern Time). ...
(Date:7/29/2014)... July 29, 2014 According to ... "Surgical Navigation Systems Market (Neurosurgical Navigation Systems, ENT Navigation ... Size, Share, Growth, Trends and Forecast, 2014 - 2020", ... USD 218.5 million in 2013 and is expected to ... 2020, to reach an estimated value of USD 295.5 ...
Breaking Medicine Technology:Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 2Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 3Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 4Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 5Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 6Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 7Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 8Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 9Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 10Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 11Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 12Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 13Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 14Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 15Sequenom, Inc. Reports Financial Results For The Second Quarter Of 2014 16Landauer, Inc. Sets Date and Time for Announcement of Fiscal Third Quarter 2014 Results 2Surgical Navigation Systems Market Expected to Reach USD 295.5 Million Globally in 2020: Transparency Market Research 2Surgical Navigation Systems Market Expected to Reach USD 295.5 Million Globally in 2020: Transparency Market Research 3Surgical Navigation Systems Market Expected to Reach USD 295.5 Million Globally in 2020: Transparency Market Research 4
... (NASDAQ: THOR), a world leader in device-based mechanical circulatory ... said today it will be participating in the Oppenheimer ... 13. Taylor C. Harris, Senior Director of ... on the company, beginning at 10:15 a.m., Eastern Standard ...
... Dec. 9, 2011 Quest Diagnostics Incorporated (NYSE: ... testing, information and services, announced that Care360™, the company,s ... e-Prescribing software system by Black Book Rankings, a leading ... services and software industries. Black Book ...
Cached Medicine Technology:Quest Diagnostics Care360™ Named Top e-Prescribing Platform by Black Book Rankings 2Quest Diagnostics Care360™ Named Top e-Prescribing Platform by Black Book Rankings 3
... With a zoom ratio of ... 0.75X to 11.25X, and the ... intervals from 1X to 11X, ... Magnifications of 3.75X to 540X ...
Inquire...
... apochromatically corrected objectives for ... most exacting demands in ... suitable for visual field ... mm and feature sufficiently ...
... working distances with high Numerical Apertures, these ... optical aberrations throughout the visible spectrum from ... across the entire 25mm field of view. ... colour reproduction, plus resolving power at the ...
Medicine Products: