Daiichi Sankyo Files New Drug Application for Amoldipine Beslyte, Olmesartan Medoxomil Combination for Hypertension Treatment.Tokyo, Japan, Nov 30, 2006 - (JCN) - Daiichi Sankyo announced November 29 that it has filed a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for a fixed dose combination A fixed dose combination (FDC) is a formulation of two or more active ingredients combined in a single dosage form available in certain fixed doses. Fixed dose combination drug products may improve medication compliance by reducing the pill burden of patients. of two antihypertensives, the calcium channel blocker calcium channel blocker n. Any of a class of drugs that inhibit movement of calcium ions across a cell membrane, used in the treatment of cardiovascular disorders. (CCB CCB Calcium channel blocker, see there ) amlodipine besylate (currently marketed by Pfizer as Norvasc) and the angiotensin receptor blocker (ARB) olmesartan medoxomil, or Benicar. Pending approval, the combination will be indicated for the treatment of hypertension and may be used either alone or in combination with other antihypertensive agents. In a clinical trial, the amlodipine/olmesartan combination demonstrated clinically significant mean blood pressure reductions. It utilizes two complementary mechanisms of action, calcium channel blockade and angiotensin II receptor blockade. Benicar, Daiichi Sankyo's currently marketed ARB, is the fastest growing medication in the fastest growing class of blood pressure-lowering drugs. Norvasc is the most widely used CCB on the market. Copyright [c] 2006 Japan Corporate News Network. All rights reserved. |
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