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

By Carina Storrs
HealthDay Reporter

WEDNESDAY, Dec. 5 (HealthDay News) -- People taking the antidepressant Wellbutrin now have one less option for a generic version of the drug.

In October, the U.S. Food and Drug Administration recommended that generic Wellbutrin, or bupropion, made by Impax Laboratories and distributed by Teva Pharmaceuticals, be taken off the market, and Impax and Teva have agreed to stop shipping the drug.

The decision is based on an FDA study that found that the extended release (XL) form of bupropion -- Budeprion XL -- at the 300 milligram (mg) dose was not bioequivalent to brand-name Wellbutrin XL at the same dose, suggesting that it may not be as safe and effective.

The study was published Dec. 5 in the New England Journal of Medicine.

Four other manufacturers make bupropion XL in 300 mg tablets, and patients can still get their prescription filled with these products.

"The other four generic versions of 300 mg extended-release bupropion tablets are not affected by FDA's recent announcement," said FDA spokesperson Sandy Walsh.

Although the agency stated that lack of bioequivalence might only apply to the Impax/Teva product because of its unique formulation, the agency is requesting that the other four manufacturers submit bioequivalence data to the agency by March 2013.

"This kind of result puts a cloud over all of the generic XL [forms of bupropion]," said Dr. David Hellerstein, a professor of psychiatry at Columbia University Medical Center, in New York City.

Companies including Impax/Teva also make a bupropion XL in 150-mg tablets, which are also not affected by the FDA decision.

But even before the FDA decision, Hellerstein avoided any kind of generic bupropion XL. "Patient would complain that generic XL is not the same as brand-name XL -- it wears off sooner, it has more side effects," he said. "I tell patients not to go to XL unless you're
'/>"/>

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:8/22/2014)... An increasing number of mergers and acquisitions ... market. M&As provide financial assistance to smaller companies, increase ... distribution channels of companies and help in increasing the ... According to the “ Global Animal Health Market 2014-2018 ... diet is one of the major drivers in the ...
(Date:8/22/2014)... August 22, 2014 The international ... Clinics are promoting non-invasive screening, risk assessment and ... of cardiovascular morbidity and mortality, even in asymptomatic ... Vein Thrombosis and Pulmonary Embolus, and Peripheral Vascular ... painless, noninvasive screening at accredited facilities at all ...
(Date:8/22/2014)... On October 10, 2014, Dr. ... present an in-depth workshop on mindfulness and biofeedback ... the one-day workshop, participants will learn how to ... practice. , According to Dr. Khazan, "Biofeedback is ... control their physiological responses. However, extensive research shows ...
(Date:8/22/2014)... FastFingerprints is adding a new location to the ... August 27, 2014 and is located at 3740 Euclid ... addition of this new office, that will bring the ... area. Our new Cleveland-Midtown location will provide live ... of operation will be Monday-Friday 8:00am – 5:00pm with ...
(Date:8/22/2014)... Teen substance abuse has long been a ... numbers of young adults falling victim to a drug or ... a difference in the community, the new Troubled Teens Toledo ... seeking to overcome their chemical dependency. The helpline is designed ... rehab center to focus on achieving sobriety. , By contacting ...
Breaking Medicine News(10 mins):Health News:Global Animal Health Market 2014-2018 a New Research Report Added to ReportsnReports.com 2Health News:Global Animal Health Market 2014-2018 a New Research Report Added to ReportsnReports.com 3Health News:Global Animal Health Market 2014-2018 a New Research Report Added to ReportsnReports.com 4Health News:NY Heart Health Clinics Created by Dr. David Greuner and Dr. David Luu of NYC Surgical Associates 2Health News:NY Heart Health Clinics Created by Dr. David Greuner and Dr. David Luu of NYC Surgical Associates 3Health News:Mindfulness Expert and Author Dr. Inna Khazan to Present One-day Workshop In Montreal on Integrating Mindfulness Based Skills Into a Biofeedback Practice 2Health News:Mindfulness Expert and Author Dr. Inna Khazan to Present One-day Workshop In Montreal on Integrating Mindfulness Based Skills Into a Biofeedback Practice 3Health News:FastFingerprints Expands In The Cleveland Ohio Area 2Health News:FastFingerprints Expands In The Cleveland Ohio Area 3Health News:New Helpline Provides Hope for Troubled Teens in Toledo 2
... , MARINA DEL REY, Calif., Sept. 21 ... health care formula prescribed by Dr. Richard Merkin, CEO for Heritage ... Healthcare Partners IPA in New York have been eliminating waste and ... past 30 years by focusing on the importance of integrating electronic ...
... , , ... Councilman Larry Seabrook, City Council Member for District 12 in ... Friday September 11, 2009. More than 700 residents from Co-Op ... Seabrook honoring community heroes including Mayor David Dinkins, Roscoe Brown, ...
... , , WASHINGTON, Sept. 21 ... regulation are expected as the Senate Finance Committee considers a ... offset the costs of health care reform. The amendment ... tax revenue generated through implementation of the currently pending Internet ...
... , , BELMONT, Calif., ... focused on improving the lives of patients with sleep-disordered breathing, ... the Runners-Up Award in The Wall Street Journal ... were published in the September 14, 2009 edition of ...
... Sept. 21 DHA omega-3 innovator and maker of the ... announced today that life,sDHA is featured in the new ... brand from Ragasa Industries. This is the first product launch from ... cooking oil to feature DHA for brain health. The life,sDHA ...
... follow the rules, the laws are too lax, study shows ... appear to be largely abiding by parental consent laws, but ... to harmful ultraviolet rays, a new study shows. , Tanning ... as long as they had parental consent, they could tan ...
Cached Medicine News:Health News:Heritage Provider Network and Dr. Richard Merkin Highlight Cutting Health Care Costs Using Electronic Medical Records 2Health News:HealthCare Partners, IPA, Dr. Richard Merkin, CEO and Councilman Larry Seabrook Celebrate Salute to Our Heroes on 9/11 2Health News:HealthCare Partners, IPA, Dr. Richard Merkin, CEO and Councilman Larry Seabrook Celebrate Salute to Our Heroes on 9/11 3Health News:Senator Proposes Use of Internet Gambling Revenue to Help Fund Health Care Reform 2Health News:Ventus Medical Announces PROVENT(R) Sleep Apnea Therapy Recognized by The Wall Street Journal 2009 Technology Innovation Awards 2Health News:Ventus Medical Announces PROVENT(R) Sleep Apnea Therapy Recognized by The Wall Street Journal 2009 Technology Innovation Awards 3Health News:Martek's life'sDHA(TM) Featured in New Nutrioli DHA Cooking Oil from Ragasa 2Health News:Martek's life'sDHA(TM) Featured in New Nutrioli DHA Cooking Oil from Ragasa 3Health News:Many Teens Circumvent Tanning Bed Laws 2Health News:Many Teens Circumvent Tanning Bed Laws 3
(Date:8/21/2014)... , Aug. 21, 2014   Auxilium ... a specialty biopharmaceutical company, today announced positive results ... collagenase clostridium histolyticum (or CCH) for the treatment ... cellulite. In the Phase 2a trial, all three ... high (0.84mg)) showed an improvement in the appearance ...
(Date:8/20/2014)... LUTHERVILLE, Md. , Aug. 20, 2014 /PRNewswire/ ... today lauded the latest results achieved by the ... known as the National Precursor Log Exchange (NPLEx), ... enforcement officials track down meth offenders and make ... in Indiana blocked the ...
(Date:8/20/2014)... 20, 2014 The National Association of ... results achieved by the real-time, pseudoephedrine (PSE) blocking ... Precursor Log Exchange (NPLEx), automatically blocks unlawful pseudoephedrine ... meth offenders and make arrests. Data released by ... blocked the sale of more than ...
Breaking Medicine Technology:Auxilium Pharmaceuticals, Inc. Announces Positive Data From Phase 2a Study Of CCH In Patients With Cellulite 2Auxilium Pharmaceuticals, Inc. Announces Positive Data From Phase 2a Study Of CCH In Patients With Cellulite 3Auxilium Pharmaceuticals, Inc. Announces Positive Data From Phase 2a Study Of CCH In Patients With Cellulite 4Auxilium Pharmaceuticals, Inc. Announces Positive Data From Phase 2a Study Of CCH In Patients With Cellulite 5Auxilium Pharmaceuticals, Inc. Announces Positive Data From Phase 2a Study Of CCH In Patients With Cellulite 6Auxilium Pharmaceuticals, Inc. Announces Positive Data From Phase 2a Study Of CCH In Patients With Cellulite 7Indiana's Stop-Sale System Achieves Significant Results In Battle Against Meth 2Kansas's Stop-Sale System Achieves Significant Results In Battle Against Meth 2
... venture capital and neurodevice commercialization company has opened a ... to its Cleveland, Ohio headquarters and North Carolina Research ... medical device industry veteran Mark Stultz, NDI,s recently hired ... http://photos.prnewswire.com/prnh/20111201/DC13950 ) ...
... Calif., Dec. 1, 2011  Agensys, Inc. ("Agensys"), a ... P. Hudson has been appointed vice president of ... vice president of process sciences and manufacturing. ... experience from the biopharma industry to their respective ...
Cached Medicine Technology:NDI Brings on Industry Veteran Mark Stultz to Head Up New Minneapolis Office 2Astellas Adds Two Key Senior Executives at Agensys, Inc. 2Astellas Adds Two Key Senior Executives at Agensys, Inc. 3
Round handle dull finish. For right handed surgeon....
Specially designed wider jaws to help split soft nucleus, cross action, round handle, maximum opening 2.8 mm....
Specially designed wider jaws to help split soft nucleus, cross action, round handle, maximum opening 2.8 mm....
Cross action, round handle, maximum opening 2.8 mm....
Medicine Products: