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, including those products marketed under the name of Tigan containing trimethobenzamide.

Because DESI findings apply to any unapproved products that are identical, related, or similar to DESI-reviewed drugs, today's notice makes the marketing of any unapproved trimethobenzamide hydrochloride suppository products unlawful.

'Prescription drugs that have not gone through the FDA approval process are of unproven safety and effectiveness,' said director of CDER's Office of Compliance, Deborah M. Autor. 'Today's action helps ensure that health care providers prescribe, and consumers take, only medicines shown to be effective.'

Companies manufacturing or marketing trimethobenzamide hydrochloride suppository products must cease shipping them in interstate commerce by May 9, 2007. A small amount of these products will still be available in pharmacies after that date until supplies are exhausted. Any company wishing to market a product containing trimethobenzamide in suppository form must now obtain an approved new drug application prior to marketing.

This action is the next step in a concerted FDA effort to ensure that all marketed U.S. drugs have required FDA approval. In June of last year, FDA announced its renewed emphasis on this issue and sent a clear signal to industry that FDA expects all marketed drugs to have required FDA approval, and that the agency will take action to make that happen. At that time, FDA published a Compliance Policy Guide or CPG, which is a guidance document that describes the agency's risk-based enforcement approach to marketed unapproved drugs. Completing DESI proceedings is a separate but important part of tackling the unapproved drugs problem. Source: FDA
SRM/B
'"/>




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:
*Name:
*Comment:
*Email:


(Date:5/27/2016)... NY (PRWEB) , ... May 27, 2016 , ... ... with Mediaplanet to help educate the many who are unaware of the plight ... to aphasia will run within the “Stroke Awareness” campaign. , The link between ...
(Date:5/27/2016)... ... ... Aimed at nurses and employees in the health care world, this installment ... nursing and health care industry. It also provides insight to the developing trends and ... As the nursing industry is coming out of one of the biggest recessions in ...
(Date:5/26/2016)... ... May 26, 2016 , ... Despite last week’s media reports hinting ... and company to wait until March 2017 for an interest rate increase, according to ... College of Business. , “The Federal Open Market Committee (FOMC) dot charts are of ...
(Date:5/26/2016)... ... May 26, 2016 , ... Cabot ... of defective respirators, according to court documents and SEC filings. A jury ... Becky Tyler v. American Optical Corporation, Case No. BC588866, Los Angeles County, California. ...
(Date:5/26/2016)... ... , ... Connor Sports, through its Connor Cares initiative, will continue ... Catchings Legacy Tour that will commemorate the Indiana Fever legend’s hall-of-fame career and ... forms and levels of the game, Connor Sports has committed to a significantly increased ...
Breaking Medicine News(10 mins):
(Date:5/26/2016)... , May 26, 2016   ... software and analytics, network solutions and technology-enabled ... announced it entered into a strategic channel ... of outpatient software solutions and revenue cycle ... specialty hospitals and rehabilitation clinics to optimize ...
(Date:5/25/2016)... -- FDA 510(k) clearance covers Confocal ... urological and surgical applications Mauna Kea ... the multidisciplinary confocal laser endomicroscopy (CLE) platform, today ... with the 12 th 510(k) clearance from ... new FDA clearance covers Confocal Miniprobes indicated for ...
(Date:5/25/2016)... , Deutschland und GERMANTOWN, Maryland ... Zusammenarbeit mit Therawis bedient ... bei Brustkrebs   QIAGEN N.V. (NASDAQ: ... gab heute bekannt, eine Lizenz- und Entwicklungsvereinbarung mit ... Assays für die Onkologie eingegangen zu sein. Ein ...
Breaking Medicine Technology: