Navigation Links
Abbott Statement on the FDA Advisory Committee Recommendation on Sibutramine
Date:9/15/2010

).  In response to the Advisory Committee's mixed vote, Abbott (NYSE: ABT) issued the following statement:

"Today's vote highlights the complexity of this scientific debate," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott.  "We continue to believe that there are appropriate and identifiable patients that derive benefit from sibutramine.  Sibutramine is an important option for patients and physicians to treat a serious condition for which there are few treatment options currently available, and Abbott has proposed comprehensive risk management tools to ensure that physicians and patients have the most relevant information for the continued appropriate use of sibutramine."

"Sibutramine has been studied in more than 100 clinical trials involving more than 20,000 patients, in addition to those involved in the SCOUT study," said Sun.  "SCOUT did not directly assess the risk/benefit profile of the medication in patients for whom it is specifically intended and its results cannot be readily extrapolated to the approved patient population, that is, patients who do not have a history of cardiovascular disease."

The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee will be considered by the FDA during its decision-making process for Meridia.  Abbott intends to consult with the FDA on sibutramine moving forward.

Sibutramine is approved for weight loss in patients who are either obese or overweight, and have no previous history of cardiovascular disease.  The approximately 10,000-patient, six-year SCOUT study was requested by European regulatory authorities as a post-marketing commitment.  More than 90 percent of the patients studied in SCOUT had underlying cardiovascular disease or were otherwise ineligible to receive sibutramine under the current labeling and prescribing inf
'/>"/>

SOURCE Abbott
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Abbott Honored for Workplace Leadership for the Tenth Consecutive Year by Working Mother Magazine
2. Abbott Included on the Dow Jones Sustainability Indexes for Six Consecutive Years in Recognition of Leading Corporate Citizenship Performance
3. Abbott Completes Acquisition of Piramals Healthcare Solutions Business, Becomes Leading Pharmaceutical Company in India
4. Abbott Receives FDA Approval for First Automated Molecular Test for Assessing Hepatitis B Treatment
5. Abbott to Present at Morgan Stanley Global Healthcare Unplugged Conference
6. Abbotts SIMCOR ® ( niacin extended-release / simvastatin ) Receives FDA Approval for New Dosage Strengths
7. Abbott to Feature Novel Tests and New Upgrades to Testing Platforms at American Association for Clinical Chemistry Lab Expo
8. Abbott Receives FDA Clearance for Molecular Diagnostic Test for Detection of Chlamydia and Gonorrhea Infections
9. Abbott to Present Data on Several Investigational Cancer Treatments at American Society of Clinical Oncology Annual Meeting
10. The New England Journal of Medicine Publishes Results of Landmark CREST Study, Showing Similar Positive Outcomes for Abbotts Carotid Stent System and Surgery
11. Abbotts Groundbreaking Bioresorbable Technology Continues to Demonstrate Exceptional Clinical Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... Breckenridge Pharmaceutical, Inc. announced today that it ... Pvt. Ltd. ( Hyderabad, India ) under ... ANDAs.  Under the terms of the agreement, MSN will ... for the U.S. market, and Breckenridge will market and ... have agreed to develop an oral antibiotic with current ...
(Date:12/19/2014)... 19, 2014  Monarch America Inc. (OTCQB: CANK) ("Monarch ... pleased to provide this review of the Company,s recent ... "Over this past year, we achieved many ... extremely proud to say that Monarch America is in ... has ever been," stated Eric Hagen , CEO ...
(Date:12/19/2014)... --Research and Markets ( http://www.researchandmarkets.com/research/942kh3/micro_market ) ... Market Monitor: North American Dermatology Diagnostic Devices Market" ... http://photos.prnewswire.com/prnh/20130307/600769 Cosmetic surgeries ... resulted in fueling the overall demand of the ... these dermatology devices is to assist in identifying ...
Breaking Medicine Technology:Breckenridge Pharmaceutical signs Multi-Product Generic Agreement with MSN Laboratories Pvt. Ltd. 2Monarch America Inc. CEO Reviews Recent Achievements and Provides Outlook for 2015 2Monarch America Inc. CEO Reviews Recent Achievements and Provides Outlook for 2015 3Micro Market Monitor: North American Dermatology Diagnostic Devices Market 2Micro Market Monitor: North American Dermatology Diagnostic Devices Market 3
... ... - Spreads Messages of Hope to Others with Diabetes and Steers Toward Its ... of Tour de France Competition, BRIDGEWATER, N.J., April 2, 2008 ,Sanofi-aventis announced today ... of,Team Type 1, a team of amateur and professional cyclists living with type 1,diabetes., ...
... Therapeutics,Inc. (CTI) (Nasdaq: CTIC ; MTA) today ... for review CTI,s Marketing Authorization,Application (MAA) for XYOTAX(TM) ... non-small cell lung cancer (NSCLC),with ECOG (Eastern Cooperative ... MAA at the beginning of March. The validation ...
Cached Medicine Technology:Elite Team of Cyclists with Type 1 Diabetes Powers Forward in 2008 Sponsored by Rapid-Acting Insulin Apidra(R) 2Elite Team of Cyclists with Type 1 Diabetes Powers Forward in 2008 Sponsored by Rapid-Acting Insulin Apidra(R) 3Elite Team of Cyclists with Type 1 Diabetes Powers Forward in 2008 Sponsored by Rapid-Acting Insulin Apidra(R) 4Elite Team of Cyclists with Type 1 Diabetes Powers Forward in 2008 Sponsored by Rapid-Acting Insulin Apidra(R) 5European Regulatory Agency Accepts Cell Therapeutics, Inc.'s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review 2European Regulatory Agency Accepts Cell Therapeutics, Inc.'s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review 3European Regulatory Agency Accepts Cell Therapeutics, Inc.'s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review 4
(Date:12/22/2014)... Physicians in China are most eagerly ... of non-Hodgkin’s lymphoma (NHL), according to a new report ... consulting firm. MabThera is the only biologic available to ... form of NHL. , According to Kantar Health’s report, ... of NHL in China has been growing and is ...
(Date:12/22/2014)... 2014 Give a loved one the ... of health and vitality. , For a limited time, ... anti-aging formulas in special Holiday Wellness gift packages at ... , Each bottle contains cutting-edge, proven nutritional support for ... as well as we age. , Joint ...
(Date:12/22/2014)... Austin, Texas (PRWEB) December 22, 2014 ... hustle and bustle of Black Friday shopping and opted ... publishing and marketing education company, for their 5th annual ... Marketer charged just $7 to attend the 5 ... sales that they promptly donated to support two Central ...
(Date:12/22/2014)... 22, 2014 NAPW honors ... Woman of the Year. She is recognized with this ... most recognized networking organization of professional women in the ... Association of Professional Women is a vibrant networking community ... , Ms. Kreider is passionate and committed to best ...
(Date:12/21/2014)... In this report, the global powered ... product, and application. The market, by power source, ... By product, the market covers the handpieces; power ... market is further subdivided into drills, saws, reamers, ... shavers, wire/pin drivers, and others. Moreover, the power ...
Breaking Medicine News(10 mins):Health News:Physicians in China See Most Significant Demand for MabThera Biosimilar 2Health News:Physicians in China See Most Significant Demand for MabThera Biosimilar 3Health News:You Still Have Time to Give the Gift of Health and Vitality to a Mature Loved One 2Health News:Austin Company Digital Marketer Raises 100K to Fight Childhood Cancer 2Health News:Austin Company Digital Marketer Raises 100K to Fight Childhood Cancer 3Health News:National Association of Professional Women Announces Cheryl A. Kreider, President / CEO of Kreider Health Solutions, LLC, a 2014 Professional Woman of the Year 2Health News:Global Powered Surgical Instruments Market Hit to $2.1 billion by 2019 - New Research Report by MarketsandMarkets 2Health News:Global Powered Surgical Instruments Market Hit to $2.1 billion by 2019 - New Research Report by MarketsandMarkets 3Health News:Global Powered Surgical Instruments Market Hit to $2.1 billion by 2019 - New Research Report by MarketsandMarkets 4
... May 6 Volcano Corporation (Nasdaq: VOLC ... of products for the diagnosis and treatment of coronary ... be participating in the Bank of America and Merrill ... presentation by Scott Huennekens, president and chief executive officer, ...
... Incorporated has initiated a voluntary, nationwide recall of one lot ... healthcare professionals as an aid in the diagnosis of myocardial ... to reports of low recovery of quality control samples containing ... affected lot. Although there have been no reported issues ...
... HOUSTON - A newly discovered gene known as DEAR1 is ... local recurrence-free survival in early-onset breast cancer, a research team ... Anderson Cancer Center reports in the journal PLoS Medicine ... because so many young women have recurrences in the breast, ...
... The Mobile Massage Team ( www.mobilemassageteam.com ), a ... programs, promotional events, and special affairs, today announced that the ... Annual GlobalFit Worksite Wellness Summit ( http://www.globalfit.com/summit/ ... Down Town Club in Center City Philadelphia. Team members ...
... - Leadership in Fight Against Tobacco Recognized Nationally -WASHINGTON, May ... of Greenfield, Ind., has been named the National Youth Advocate ... her leadership in the fight against tobacco. Emily is being ... 6) with four regional winners and a group winner. (Logo: ...
... released today by Ernst Berndt and Mark Trusheim of ... that eliminating FDA,s preemption protection would decrease patients, access ... reduce medical device industry employment. The paper, ... Devices on Patients, Innovation and Jobs," comes as ...
Cached Medicine News:Health News:Volcano Corporation Presentation at Bank of America/Merrill Lynch Conference to be Webcast 2Health News:Biosite Incorporated Issues Voluntary, Nationwide Recall for Cardiac Marker Test 2Health News:Novel gene predicts local recurrence in early onset breast cancer 2Health News:Novel gene predicts local recurrence in early onset breast cancer 3Health News:Campaign for Tobacco-Free Kids Honors Emily Kile, Greenfield, IN, as National Youth Advocate of the Year 2Health News:Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access 2
... TOPS is a support catheter which assists ... angioplasty or stenting. The spiral catheter offers ... with .014 to .018 steerable guidewires to ... occlusion is crossed, TOPS is withdrawn while ...
... are indicated for the removal ... thrombi from vessels in the ... also be used for temporary ... of fluids, and blood sampling. ...
Introduced more than 30 years ago by Dr. Thomas J. Fogarty, these embolectomy catheters are indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system....
The new XMI catheter incorporates the best in catheter technology to ,provide exceptional handling characteristics comparable to todays balloon catheters and stent delivery systems....
Medicine Products: