And Bristol-Myers Squibb Firm offers announced that the U.
Food and Medication Administration approved the supplemental New Drug Program for ABILIFY for the severe treatment of manic and blended episodes connected with Bipolar I Disorder, with or without psychotic features in pediatric individuals . ABILIFY has been authorized for the acute and maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults since September 2004 and March 2005, respectively.D., Medical Director, Prevention and Recognition Program, The Zucker Hillside Assistant and Hospital Professor of Psychiatry and Behavioral Sciences, Albert Einstein College of Medication, Glen Oaks, New York.D., CEO, President and Chief Operating Officer, Otsuka Pharmaceutical Commercialization and Development, Inc.D., Ph.D., Executive Vice President, Chief Scientific President and Officer, Research and Development, Bristol-Myers Squibb.Aastrom submits SPA for Stage 3 clinical development plan in critical limb ischemia to FDA Aastrom Biosciences, Inc. , a leading developer of expanded autologous cellular treatments for the treating severe cardiovascular diseases, today announced that it has submitted to the U.S. Food and Drug Administration a special protocol assessment describing the business’s proposed Phase 3 clinical development program in important limb ischemia . If the FDA concurs with the protocols outlined in the SPA, Aastrom expects to initiate the Stage 3 plan in early 2011. ‘We are pleased to have reached this important milestone for our CLI program and our programs for the Phase 3 pivotal clinical program remain on track,’ said Tim Mayleben, president and CEO of Aastrom. ‘Proceeding through the FDA’s SPA process will help make sure consensus with FDA on trial style and endpoints, and can provide a obvious and objective path forwards as we progress our first-of-a-kind therapy for severely ill CLI individuals.’ CLI may be the most severe form of peripheral artery disease, leading to over 160,000 main limb amputations each year in the U.S.