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:12/8/2016)... Tampa, FL (PRWEB) , ... December 08, 2016 ... ... been awarded accreditation with distinction by the Undersea and Hyperbaric Medical Society (UHMS), ... patients with advanced care and patient safety. Only a few hospitals and facilities ...
(Date:12/8/2016)... ... December 08, 2016 , ... ZyDoc ... Language Processing–Enabled and Conventional Data Capture Methods for Input to Electronic Health Records: ... , Results of the comparative usability study demonstrate that a dictation-based method (“NLP ...
(Date:12/8/2016)... ... December 08, 2016 , ... CURE Media Group, the nation’s leading ... has aligned with Upstage Lung Cancer in efforts to combat lung cancer, announced CURE ... Hennessy, Jr said, “CURE Media Group is honored to team up with Upstage Lung ...
(Date:12/8/2016)... ... December 08, 2016 , ... Premier Fitness Camp (PFC) and The Chopra ... weight loss and wellness program, at their world headquarters of Omni La Costa Resort ... long-term results to anyone seeking weight loss, personal development, a healthy lifestyle, or mental ...
(Date:12/8/2016)... ... December 08, 2016 , ... Catalent Pharma Solutions, the leading ... consumer health products, today announced that it had joined the Pharmaceutical Supply Chain ... organization to unite pharmaceutical and healthcare companies that share a vision of better, ...
Breaking Medicine News(10 mins):
(Date:12/9/2016)... LONDON , December 9, 2016 ... ICD, Subcutaneous ICD, Single-Chamber ICD, Dual-Chamber ICD, Cardiac ... External Defibrillators, Wearable Cardioverter Defibrillators The ... grow at a CAGR of 5.3% from 2016-2020 ... is expected to grow at a CAGR of ...
(Date:12/9/2016)... Research and Markets has announced the addition of the "High ... offering. ... analyses the market by the following Technology Types: Label-Free Technology, Cell-Based Assay, ... Canada , Japan , Europe ... , and Rest of World. Annual estimates and forecasts ...
(Date:12/9/2016)... Research and Markets has announced the ... 2021" report to their offering. ... Market growth can be ... the pharmaceutical and biotechnology industry and technological advancements like automation ... markets and growing research activities in toxicology and stem cells ...
Breaking Medicine Technology: