Navigation Links
FDA Announces to Companies to Stop Marketing Products Containing Trimethobenzamide

Food and Drug Administration's (FDA) has announced that companies must stop manufacturing and distributing unapproved suppository drug products// containing trimethobenzamide hydrochloride. The declaration has come in the wake of on-going initiative to ensure that all marketed U.S. drugs have required marketing approval.

These products are used to treat nausea and vomiting in adults and children. Drugs containing trimethobenzamide in suppository form lack evidence of effectiveness. These products have been marketed under various names, including Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz.

FDA urges consumers who are using suppositories containing trimethobenzamide, and who have questions or concerns, to contact their health care provider. There are many alternative products approved to effectively treat nausea and vomiting, and that are available in a variety of forms, including tablets, capsules, solutions, injectables and suppositories. Several oral capsules and injectable products containing trimethobenzamide have been approved by FDA and are not affected by today's action.

'FDA is continuing its work to remove unapproved drugs from the market,' said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research (CDER). 'FDA is committed to ensuring that the medicines Americans rely on when they are sick are proven to be effective and safe.'

The Federal Register notice http://www.fda.gov/OHRMS/DOCKETS/ 98fr/78n-0224-nwl0002.pdf which outlines the agency's order to manufacturers and distributors, also concludes all outstanding issues for drugs containing trimethobenzamide, under the Drug Efficacy Study Implementation program (DESI). In 1962, Congress amended the Federal Food, Drug, and Cosmetic Act to require that drugs be shown to be effective, as well as safe. Under DESI, FDA evaluated the evidence of effectiveness for thousands of drug products previously approved for safety only,
'"/>




Page: 1 2

Related medicine news :

1. Ramdoss Announces Introduction of RCH-II
2. Britain Announces Third Transfusion Related Mad Cow Case
3. Tibet Announces the Dalai Lama’s Tour of South Americ
4. Indian PM Announces Of Setting Up India Study Center At Tashkent
5. PowderMed Announces Needle-Less Flu Vaccine
6. Malaysia Announces Prison term On People Donating HIV-Contaminated Blood
7. Gates Foundation Announces $287 Million In Grants Towards AIDS Vaccine
8. Australian Government Announces Survey To Tackle Childhood Obesity
9. New Zealand Announces 10-year Plan For Betterment Of Mental Health Care
10. Apollo Announces Research on Indian Cardiac Epidemic
11. Government Announces Steps To Promote Ayurvedic Medicine
Post Your Comments:
(Date:7/23/2014)... Oklahoma (PRWEB) July 23, 2014 ... America’s leading provider of in-home care for seniors, ... Longevity Webinar Series featuring experts in a wide ... webinar will feature licensed clinical social worker and ... most common causes of caregiver stress and ways ...
(Date:7/23/2014)... If past experience is anything to go by, ... get a lot more recognition for their contributions to ... allowing NPs to provide primary care offer nurses more ... relationships with physicians and administrators, compared with colleagues in ... School of Nursing, published in Health Care Management ...
(Date:7/23/2014)... (PRWEB) July 23, 2014 Celebrating a ... New Jersey today announced the awarding of $1,070,000 in ... special award in recognition of the Foundation’s 1,000th grant. ... to continue our tradition of supporting community-based organizations that ... quality of life in the Garden State,” said Robert ...
(Date:7/23/2014)... a growing body of research suggesting a safe ... treating postmenopausal breast cancer, with fewer detrimental side ... anti-hormone therapies. The study will be published in ... Reproductive Biology and Endocrinology . , Breast cancer ... in the United States. Approximately 70% of breast ...
(Date:7/23/2014)... 23, 2014 Global Cardio Care, Inc., ... External Counterpulsation (EECP), is celebrating the 100th birthday ... at the health center. , Weber has been ... receiving ongoing EECP therapy since 1999, he no longer ... CEO of Global Cardio Care, introduced the Sara ...
Breaking Medicine News(10 mins):Health News:Oklahoma Home Care Assistance Hosting Caregiver Mindfulness Webinar Tomorrow 2Health News:Oklahoma Home Care Assistance Hosting Caregiver Mindfulness Webinar Tomorrow 3Health News:New York law offers nurses more recognition, responsibility 2Health News:The Horizon Foundation for New Jersey Awards More than $1 million in Grants to 20 Non-profit Organizations 2Health News:The Horizon Foundation for New Jersey Awards More than $1 million in Grants to 20 Non-profit Organizations 3Health News:The Horizon Foundation for New Jersey Awards More than $1 million in Grants to 20 Non-profit Organizations 4Health News:The Horizon Foundation for New Jersey Awards More than $1 million in Grants to 20 Non-profit Organizations 5Health News:Hormones after breast cancer: Not fuel for the fire after all? 2Health News:Hormones after breast cancer: Not fuel for the fire after all? 3Health News:Hormones after breast cancer: Not fuel for the fire after all? 4Health News:Hormones after breast cancer: Not fuel for the fire after all? 5Health News:Global Cardio Care Celebrates EECP Patient’s 100th Birthday 2
... completely implantable artificial heart was approved by the U.S. ... heart has been approved for patients with severe heart ... ,Under the FDA's Humanitarian Use Device provisions, ... However, it restricts the use of more than 4,000 ...
... 300 million poultry next month against bird flu.// ... large-scale criticism over the country's efforts to stamp out ... mass vaccination today. Indonesia has the world's highest human ... in the world and scientists and the World Bank ...
... An engineer has developed a new system that could help ... ,An engineer Fernando Silvio Nu?o Almirantearena has developed a ... heart attack, brain stroke or high blood pressure, by determining ... techniques. Fernando has outlined in his thesis for PhD the ...
... in the Journal of Clinical Investigation and the September issue ... that a new drug helps in reducing the risk of ... flow in diseased arteries. The new drug developed by ... by free radicals, which helps in dilatation of the arteries. ...
... worked at Ground Zero after 9/11 are struggling with serious ... advocates.// "When we were needed on 9/11, no one asked ... said Lucelly Gil, who was present in the disaster zone. ... illegal immigrants to work in danger zone without providing the ...
... asked EU health authorities to re-examine data related to ... Committee for Medicinal Products for Human Use (CHMP) had ... cancer need new treatment options like Tarceva, which has ... and has already been approved for this indication in ...
Cached Medicine News:Health News:First Implantable artificial heart gets FDA’s approva 2Health News:Indonesia To Conduct Mass Vaccination Of Poultry 2Health News:A New System Developed For Studying The Condition Of The Human Arterial System 2Health News:A New Drug That Could Revolutionize Management Of Heart Disease 2
(Date:7/23/2014)... 2014 The Board of Directors of VirtualScopics, ... of clinical trial imaging solutions, announced today that ... and chief executive officer, effective immediately.  Mr. Converse joined ... has held the positions of interim president and chief ... Charles E. Phelps , Ph.D., chairman of the ...
(Date:7/23/2014)... , July 23, 2014 ... PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM ANY JURISDICTION ... RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION. AbbVie ... financial results on Friday, July 25, 2014, before the market ... the earnings conference call at 8 a.m. Central time (9 ...
(Date:7/23/2014)... , July 23, 2014 /PRNewswire-iReach/ -- Use of ... access programs to delay generic market entry results in ... a new survey and analysis by economic consulting ... Logo - http://photos.prnewswire.com/prnh/20140723/129680 Required by ... drugs and biologics, REMS programs are intended to improve ...
Breaking Medicine Technology:Eric T. Converse Named President And Chief Executive Officer Of VirtualScopics, Inc. 2Eric T. Converse Named President And Chief Executive Officer Of VirtualScopics, Inc. 3Eric T. Converse Named President And Chief Executive Officer Of VirtualScopics, Inc. 4AbbVie to Host Second-Quarter Earnings Conference Call 2AbbVie to Host Second-Quarter Earnings Conference Call 3AbbVie to Host Second-Quarter Earnings Conference Call 4AbbVie to Host Second-Quarter Earnings Conference Call 5AbbVie to Host Second-Quarter Earnings Conference Call 6New Analysis Finds $5.4 Billion In Annual Lost Savings From Strategies Geared Toward Delaying Generic Drug Entry 2
... Pharmaceuticals, Inc. (NYSE Amex: INO ), a ... against cancers and infectious diseases, has expanded its scientific ... in the fields of vaccines and cancer immunotherapeutics. Joining ... Professor of the Scripps Research Institute and founder of ...
... The Board of Directors of MSA (NYSE: MSA ... President of the company, responsible for Global Product Leadership.  Dr. ... 1, will assume the role of President of MSA International, ... his new role, Dr. Muschter will become a member of ...
Cached Medicine Technology:Inovio Pharmaceuticals Adds Two Medical Innovators to Its Scientific Advisory Board 2Inovio Pharmaceuticals Adds Two Medical Innovators to Its Scientific Advisory Board 3Inovio Pharmaceuticals Adds Two Medical Innovators to Its Scientific Advisory Board 4Inovio Pharmaceuticals Adds Two Medical Innovators to Its Scientific Advisory Board 5MSA Elects Dr. Thomas Muschter to Vice President 2
... The Featured Products are ... Mediflex and are offered ... in regular or extra ... equipped with insulation, flush ...
... Products are kept in ... are offered as 1-piece ... or extra long lengths. ... insulation, flush ports, rotating ...
... Featured Products are kept ... and are offered as ... regular or extra long ... with insulation, flush ports, ...
... The Featured Products are ... Mediflex and are offered ... in regular or extra ... equipped with insulation, flush ...
Medicine Products: