| 1. | Merck Frosst Canada - SINGULAIR® |
| | On February 23, 1997, Merck & Co, Inc made a regulatory submission for a new drug to the Food and Drug Administration (FDA) in the U.S.A., for montelukast sodium, now called SINGULAIR®. It received approval in the U.S. on February 20, 1998 and in Canada on June 17 of the same year.... |
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| 2. | Merck Frosst Canada - The Research Process |
| | The Clinical Research Group of Merck Frosst Canada is mainly involved in Phase II and III trials designed centrally by the company's US parent, Merck & Co, IncThe design of a clinical trial program often involves consultation with the US Food and Drug Administration (FDA) to ensure that the right types of trials are conducted and the right endpoints collected.. |
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| 3. | Merck Frosst Canada - Phases of Clinical Research |
| | Efficacy endpoints are usually clinically significant outcomes, often decided after consultation with the Food and Drug Administration (FDA) in the US. The duration of the study will depend on the indication - it may take up to 3 years to demonstrate a drug effect in osteoporosis, while an effect in coronary thrombosis can be demonstrated in as little as a few days.... |
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| 4. | Merck Frosst Canada - VIOXX® Information Center |
| | Independent scientific experts, including a Health Canada Expert Advisory Panel and a U.S. Food and Drug Administration Advisory Panel, concluded that the medical benefits of VIOXX outweigh the cardiovascular risks for certain patients.... |
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| 5. | Merck Frosst Canada - VIOXX® Information Center |
| | Independent scientific experts, including a U.S. Food and Drug Administration advisory panel and a Health Canada advisory panel, recently concluded that the medical benefits of VIOXX outweigh the cardiovascular risks for certain patients.... |
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| 6. | Merck Frosst Canada - Section Reserved For Media |
| | Since that time, Merck has worked with the U.S. Food and Drug Administration to provide further clarity in the product label as well as to further communicate this information to physicians.... |
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