Therapeutic Products Directorate Research Articles

The Therapeutic Products Directorate Canada has issued a Notice of Compliance approving extended-release (ER) bupropion

The Therapeutic Products Directorate Canada has issued a Notice of Compliance approving extended-release (ER) bupropion

The Therapeutic Products Directorate of Canada has issued a Notice of Compliance for metformin

The Therapeutic Products Directorate of Canada has issued a Notice of Compliance for metformin

Bureaucrat is new head of drug approvals

Health Canada has replaced the physician who headed the department's Therapeutic Products Directorate (TPD) with a political scientist and career bureaucrat. ![Figure][1]</img> Figure. Dr. Robert Peterson left Health Canada Feb. 23. Photo by: Health Canada Dr. Robert Peterson, who headed the

Drug withdrawals from the Canadian market for safety reasons, 1963-2004.

By studying drugs that have been withdrawn from the market for safety reasons, we can gain valuable insight into postmarketing surveillance as well as the process for approving new drugs. In the past decade there has been a major shift in the funding structure of the Therapeutic Products Directorate

Phosphatidylinositol increases HDL-C levels in humans

Studies have shown that phosphatidylinositol (PI) can stimulate reverse cholesterol transport by enhancing the flux of cholesterol into HDL and by promoting the transport of high density lipoprotein-cholesterol (HDL-C) to the liver and bile. The goal of this study was to determine the safety and therapeutic value of PI after oral administration to normolipidemic human subjects. We performed a randomized 2 week study in 16 normolipidemic subjects. Subjects received either 2.8 or 5.6 g of PI, with or without food. PI was well tolerated by all subjects. PI significantly affected the levels of HDL-C and triglyceride in the plasma of subjects receiving PI with food. The lower dose showed a 13% increase in HDL-C, whereas the high dose showed an increase of 18% over the 2 week period. Both low- and high-dose groups showed significant increases in plasma apolipoprotein A-I. The high dose of PI also decreased plasma triglycerides by 36% in the fed subjects. These data suggest that after only 2 weeks, PI may have a comparable therapeutic value to niacin, with negligible side effects.

Metformin Extended Release

Metformin extended release [Glumetza, metformin hydrochloride, metformin gastric retention, metformin GR] is a proprietary once-a-day formulation of metformin hydrochloride under development with Depomed for the treatment of diabetes mellitus. In May 2002, Depomed licensed manufacturing and marketing rights for its proprietary formulation of metformin extended release (500mg dose) to Biovail Corporation for the US (including Puerto Rico) and Canada. Under the terms of the agreement, Biovail will pay DepoMed a 25 million dollars milestone fee upon approval of the 500mg dosage and also customary royalties on the net sales in the US and Canada. Biovail also agreed to acquire approximately 2.4 million of additionally issued Depomed shares for 12.3 million dollars. Biovail has subsequently developed a 1000mg dose of metformin extended release [metformin XR] using its proprietary Smartcoat delivery technology allowing a graduated release of the active drug from the tablet. In April 2004, Depomed and Biovail amended their original license agreement of May 2002. Under the terms of the amended agreement, Depomed will receive royalties on sales of Biovail's 1000mg tablet in the US and Canada. In turn, Biovail acquired access to Depomed's clinical data for the metformin 500mg tablet that will be used to accelerate regulatory filings for Biovail's 1000mg tablet and establish equivalence between the two dosages. Biovail is seeking marketing partners for metformin extended release (Glumetza) in the US. The company anticipates signing an agreement for the US during the second half of 2005. In Canada, Biovail Corporation will market Glumetzatrade mark through its Canadian division, Bioval Pharmaceuticals Canada. Depomed has an agreement with LG Life Sciences for the commercialisation and distribution of metformin extended release in Korea. Metformin GR is available for partnership in Europe and Asia. Biovail Corporation and Depomed announced in June 2005 that the US FDA has approved metformin extended release (Glumetza) 500mg and 1000mg tablets for the treatment of type 2 diabetes mellitus. Biovail plans launching the product in the fourth quarter of 2005. In July 2005, Biovail paid Depomed a 25 million dollars milestone payment following approval of metformin extended release in the US for type 2 diabetes. In March 2005, Biovail Corporation and Depomed announced that they have received an approvable letter from the FDA for the once-daily, extended-release formulation of metformin extended release (Glumetza) 500mg and 1000mg tablets. The letter specified an issue related to finalising one manufacturing specification. There were no clinical labeling issues identified in the letter. Both companies filed a response to a specified issue at the FDA on 8 April 2005. The companies believed that the response will be classified as a Class I response with a 60-day review period. The 500mg dosage was developed by Depomed using its patented drug delivery GR technology, while Biovail developed metformin 1000mg dose using its proprietary Smartcoat delivery technology. Biovail's NDA for a once-daily, extended-release formulation of metformin HCl for the treatment of type II diabetes was filed in April 2004 and accepted for review in June 2004 by the FDA. Depomed completed two double-blind, pivotal, phase III clinical trials with metformin extended release 500mg at 60 sites in the US in more than 1000 patients with type 2 diabetes. In three different dosing regimens, metformin extended release significantly decreased the glycosylated haemoglobin level similarly to that of metformin immediate-release. Biovail successfully compared metformin extended release 1000mg dose with Depomed's 500mg dose in multiple equivalence studies. In these studies, metformin extended release was well tolerated and demonstrated an excellent safety profile in terms of gastrointestinal adverse events. On 1 June 2005, Depomed and Biovail Comporation, the licensee, announced that the Therapeutic Products Directorate in Canada issued a Notice of Compliance for metformin extended release (Glumetza) 500mg and 1000mg for the treatment of type 2 diabetes. Biovail Pharmaceuticals Canada plans to launch the product in the fourth quarter of 2005. Biovail has submitted an application for metformin extended release with the Therapeutic Products Directorate in Canada. and received notification of acceptance for review in August 2004. Bristol-Myers Squibb is marketing a proprietary, once-daily extended-release formulation of metformin (Glucophage XR). Several companies are developing controlled-release and extended-release formulations of metformin.

Transparency in drug regulation: Mirage or oasis?

In Canada, the information used to approve new drugs is deemed commercially sensitive and hence confidential under the Access to Information Act,[1][1] and the Therapeutic Products Directorate (TPD) will not release such information without the manufacturer's approval. As a consequence, safety and

The Therapeutic Products Directorate of Health Canada has approved Watson Pharmaceuticals' oxybutynin transdermal system

The Therapeutic Products Directorate of Health Canada has approved Watson Pharmaceuticals' oxybutynin transdermal system

119 Clinical Experience with the Self‐assembled Skin Substitue as a Biological Dressing for Chronic Venous Leg Ulcers Treatment

Introduction: Venous ulcers are the most common chronic wounds of the lower limbs. In our laboratory, the self‐assembly method is used to reconstruct autologous skin that can be used as a biological dressing (In Vitro Cell Dev Bio Anim, 1999: 35, 318; J Chem Eng, 2001: 79, 663). Goals and Methods: The aim of this study was to establish if our self‐assembled skin substitute (SASS) allows the closure of nonhealing venous leg ulcers. A case study of a 68‐year‐old woman with a chronic venous leg ulcer present for over one year and measuring 135 cm2 is thus herein presented. The autologous cells were isolated from a cutaneous biopsy (1 cm2) and cultivated in vitro(J Chem Eng, 2001: 79, 663). The autologous SASS was produced and assembled by the cells thus it does not contain any exogenous or synthetic material (In Vitro Cell Dev Bio Anim, 1999: 35, 318). The wound was debrided, covered with grafts of SASS and maintained in place with a compressive dressing (Coban, 3M, St‐Paul, MN). A new SASS was applied weekly until wound closure. The SASS seemed to lessen the pain caused by the ulcer. Seven applications of the SASS were necessary to lead to a full wound closure. Conclusion: Venous leg ulcer quickly reepithelialized after application of our SASS This case indicates that use of the SASS can reduce pain and promote closure of nonhealing leg ulcers Furthermore, we thus hope that our SASS biological dressing maybe clinically useful to treat difficult‐to‐heal leg ulcers. This study was approved by the Health Canada’s Therapeutic Products Directorate and by the Ethic Committee of the CHAUQ, Saint‐Sacrement Hospital. Acknowledgements: Fédération des Pompiers du Québec pour les Grands Brûlés.

The Therapeutic Products Directorate of Health Canada has approved gemifloxacin

The Therapeutic Products Directorate of Health Canada has approved gemifloxacin

Obituary

Birth Defects Research Part A: Clinical and Molecular TeratologyVolume 67, Issue 10 p. 823-824 Obituary Obituary Harpal S. Buttar D.V.M., Ph.D., Harpal S. Buttar D.V.M., Ph.D. Senior Scientist & Adjunct Professor Reproduction and Urology Division Therapeutic Products Directorate, Health Canada, Ottawa, Ontario, CanadaSearch for more papers by this author Harpal S. Buttar D.V.M., Ph.D., Harpal S. Buttar D.V.M., Ph.D. Senior Scientist & Adjunct Professor Reproduction and Urology Division Therapeutic Products Directorate, Health Canada, Ottawa, Ontario, CanadaSearch for more papers by this author First published: 14 October 2003 https://doi.org/10.1002/bdra.10135Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume67, Issue10October 2003Pages 823-824 RelatedInformation

Health Canada's Therapeutic Products Directorate has approved a paclitaxel-eluting coronary stent system

Health Canada's Therapeutic Products Directorate has approved a paclitaxel-eluting coronary stent system