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Notice of Compliance with conditions (NOC/c)
An NOC/c is authorization to market a drug (i.e. a Notice of Compliance (NOC)), with the condition that the sponsor undertake additional studies to verify the clinical benefit. The NOC, qualifying under the NOC/c policy, is issued under section C.08.004 of the Food and Drug Regulations.
| Brand Name | Company Name | Active Ingredient | Date of Issuance of NOC/c |
|---|---|---|---|
| Prochymal | Osiris Therapeutics, Inc. | remestemcel-L | May 17, 2012 |
| Afinitor | Novartis Pharmaceuticals Canada. Inc. | everolimus | June 30, 2011 |
| Apo-Letrozole | Apotex Incorporated | letrozole | December 9, 2010 |
| Memantine | MeliaPharm Inc. | memantine hydrochloride | October 5, 2010 |
| Riva-Memantine | Laboratoire Riva Inc. | memantine hydrochloride | March 13, 2010 |
| Sandoz Letrozole | Sandoz Canada Incorporated | letrozole | April 7, 2010 |
| TASIGNA | Novartis Pharmaceuticals Canada Inc. | nilotinib | July 22, 2010. Conditions were met on August 18, 2011. |
| DOCETAXEL for Injection | Hospira Healthcare Corporation | docetaxel | February 25, 2011 |
| TASIGNA | Novartis Pharmaceuticals Canada Inc. | nilotinib hydrochloride monohydrate | June 23, 2011 |
| pms-LETROZOLE | Pharmascience Inc. | letrozole | August 27, 2010 |
| NOVO-LETROZOLE | Novopharm Limited | letrozole | April 28, 2010 |
| Letrozole Tablets USP | Accord Healthcare Inc. | letrozole | April 28, 2010 |
| Mylan-Letrozole | Mylan Pharmaceuticals ULC | letrozole | April 28, 2010 |
| Sandoz Memantine | Sandoz Canada Incorporated | memantine hydrochloride | April 16, 2010 |
| MED-Letrozole | Generic Medical Partners | letrozole | April 28, 2010 |
| Letrozole | Cobalt Pharmaceuticals Inc. | letrozole | April 28, 2010 |
| Letrozole | Teva Canada Limited | letrozole | April 28, 2010 |
| AVASTIN | Hoffmann-La Roche Ltd. | bevacizumab | March 24, 2010 |
| GLEEVEC | Novartis Pharmaceuticals Canada Inc. | imatinib mesylate | December 22, 2009 |
| CO Memantine | Cobalt Pharmaceuticals Inc. | memantine hydrochloride | November 25, 2009 Conditions removed as of April 21, 2011 due to challenges with patient recruitment based on availability of generics and alternative treatments, and the ethics of enrolling Alzheimer's patients into placebo-controlled trials. |
| pms-Memantine | Pharmascience Inc. | memantine hydrochloride | November 4, 2009 Conditions removed as of April 21, 2011 due to challenges with patient recruitment based on availability of generics and alternative treatments, and the ethics of enrolling Alzheimer's patients into placebo-controlled trials. |
| ratio-MEMANTINE | ratiopharm inc. | memantine hydrochloride | October 29, 2009 Conditions removed as of April 21, 2011 due to challenges with patient recruitment based on availability of generics and alternative treatments, and the ethics of enrolling Alzheimer's patients into placebo-controlled trials. |
| Cayston | Gilead Sciences Canada, Inc. | aztreonam for inhalation solution | July 17, 2009 Conditions were met on May 17, 2011 |
| Avastin | Hoffman-La Roche Ltd. | bevacizumab | February 6, 2009 Avastin used in combination with paclitaxel is indicated for the treatment of patients with metastatic HER2-negative breast cancer and who are ECOG Class 0-1, has been suspended as of November 25, 2011. |
| Tasigna | Novartis Pharmaceuticals Canada Inc. | nilotinib | September 9, 2008 Conditions were met on November 30, 2011. |
| Catena | Santhera Pharmaceuticals | idebenone | July 23, 2008 |
| Vectibix | Amgen Canada Inc. | panitumumab | April 3, 2008 |
| Sutent | Pfizer Canada Inc. | sunitinab malate | May 1, 2008 Conditions were met on April 23, 2010. |
| Revlimid | Celgene | lenalidomide | January 17, 2008 |
| Isentress | Merck Frosst Canada Ltd. | raltegravir potassium | November 27, 2007 Conditions were met on March 4, 2009 |
| Lyrica | Pfizer Canada Inc. | pregabalin | November 9, 2007 Conditions were met on June 29, 2010 |
| Natrecor | Janssen-Ortho Inc. | nesiritide | November 8, 2007 |
| Atriance | GlaxoSmithKline Canada Inc. | nelarabine | September 22, 2007 |
| Sativex | GW Pharma Limited | delta-9-tetrahydrocannabinol (from Tetranabinex - Cannabis sativa L. extract) / Cannabidiol (from Nabidiolex - Cannabis sativa L. extract) | August 1, 2007 |
| Gleevec | Novartis Pharmaceuticals Canada Inc. | imatinib mesylate | May 24, 2007 |
| Sprycel | Bristol-Myers Squibb Canada | dasatinib | March 26, 2007 Conditions were met on November 19, 2009. |
| Duodopa | AbbVie Corporation, an Abbott Company | levodopa / carbidopa | Company name change November 23, 2012 March 1, 2007 |
| HepaGam B | Cangene Corporation | hepatitis B Immune Globulin | January 19, 2007 |
| Taxotere | Sanofi-aventis Canada Inc. | docetaxel | December 14, 2006 |
| Exjade | Novartis Pharmaceuticals Canada Inc. | deferasirox | October 18, 2006 |
| Femara | Novartis Pharmaceuticals Canada Inc. | letrozole | October 6, 2006 Conditions were met on December 17, 2010. |
| Sutent | Pfizer Canada Inc. | sunitinib malate | August 17, 2006 Conditions were met on April 23, 2010. |
| Prezista | Janssen-Ortho Inc. | darunavir/TMC114 | July 28, 2006 Conditions were met on February 22, 2009. |
| Nexavar | Bayer Inc. | sorafenib tablets | July 28, 2006 Conditions were met on June 12, 2009. |
| Aromasin | Pfizer Canada Inc. | exemestane | May 12, 2006 Conditions were met on June 6, 2008. |
| Xeloda | Hoffmann-La Roche Limited | capecitabine | December 7, 2005 Conditions were met on October 23, 2008. |
| Sativex | GW Pharma Limited | delta-9-tetrahydrocannabinol (from Tetranabinex - Cannabis sativa L. extract) / Cannabidiol (from Nabidiolex - Cannabis sativa L. extract) | April 15, 2005 |
| Femara | Novartis Pharmaceuticals Canada Inc. | letrozole | April 1, 2005 Conditions were met on December 17, 2010. |
| Velcade | Janssen-Ortho Inc. | bortezomib | January 27, 2005 Conditions were met on September 11, 2007 |
| Ebixa | Lundbeck Canada Inc. | memantine hydrochloride | December 8, 2004 Conditions removed as of April 21, 2011 due to challenges with patient recruitment based on availability of generics and alternative treatments, and the ethics of enrolling Alzheimer's patients into placebo-controlled trials. |
| Arimidex | AstraZeneca Canada Inc. | anastrozole | June 30, 2004. Conditions were met on December 2, 2008. |
| Celebrex | Pfizer Canada Inc. | celecoxib | May 20, 2004 Issued under the NOC/c policy *** Celebrex used for the prevention of familial adenomatous polyposis has been suspended as of December 17, 2004. |
| Replagal | Transkaryotic Therapies, Inc. | agalsidase alfa | February 6, 2004 |
| Iressa | AstraZeneca Canada Inc. | gefitinib | December 17, 2003 Conditions were met on December 18, 2009. |
| Gleevec | Novartis Pharmaceuticals Canada Inc. | imatinib | October 8, 2003 |
| Viread | Gilead Sciences, Inc. | tenofovir disoproxil fumarate | March 18, 2003 Conditions were met on July 20, 2005 |
| Casodex | Astrazeneca Canada Inc. | bicalutamide | November 25, 2002. The Notice of Compliance with Conditions was suspended on August 13, 2003 under section C.08.006(2)(a) of the Food and Drug Regulations due to submitted evidence from pivotal clinical trials demonstrating that Casodex used at a dosage of 150 mg for the treatment of localized early prostate cancer as immediate therapy is associated with increased mortality. |
| Gleevec | Novartis Pharmaceuticals Canada Inc. | imatinib | September 20, 2001 |
| Rilutek | Aventis Pharma Inc. | riluzole | August 30, 2000 Conditions were met on November 29, 2007. |
| Activase | Hoffmann-La Roche Limited | alteplase | February 16, 1999 Conditions were met on January 26, 2005 |
| NiaStase | Novo Nordisk Canada Inc. | recombinant factor VII activated | February 12, 1999 Conditions were met on May 19, 2006 |
