Astellas Pharma Submits NDA for FK506 Immunosuppressant to FDA.Tokyo, Japan, Dec 26, 2005 - (JCN JCN Japan Corporate News JCN Journal of Cognitive Neuroscience JCN Journal of Cardiovascular Nursing JCN Journal of Christian Nursing JCN Job Control Number JCN Journal of Child Neurology JCN joint communications network (US DoD) ) - Astellas Pharma Astellas Pharma Inc. (アステラス製薬株式会社 announced on December 26 that its US subsidiary Astellas Pharma US has filed a New Drug Application for FK506 modified release formulation (tacrolimus), its proprietary immunosuppressant immunosuppressant /im·mu·no·sup·pres·sant/ (-sah-pres´ant) an agent capable of suppressing immune responses. im·mu·no·sup·pres·sant n. An agent that suppresses the body's immune response. , with the US 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. ). The subsidiary is seeking approval to use the agent for preventing rejection in patients who have organ transplants. FK 506 (tacrolimus), which was discovered by Astellas Pharma, is now prescribed in about 70 countries worldwide under the trade name of Prograf. The modified release formulation of FK506 is currently in Phase II trials in Japan and in preparation for application in Europe. Copyright [c] 2005 Japan Corporate News Network. All rights reserved. |
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