Otsuka Pharma Europe Withdraws Abilify Extension Application
MAIN FACTS:
-Abilify was expected to be used in the treatment of major depressive episodes.
-The application for the extension of indication for Abilify was submitted to the Agency on Dec. 11 2008.
-The company stated in its official letter that the withdrawal was based on the CHMP's consideration that the long-term data provided in support of the proposed indication were insufficient, as long-term randomized controlled data are needed before this indication can be licensed.
-Abilify continues to be authorized for the currently approved indications.
-By London Bureau, Dow Jones Newswires; Contact Ian Walker; +44 (0)20 7842 9296; ian.walker@dowjones.com Click here to go to Dow Jones NewsPlus, a web front page of today's most important business and market news, analysis and commentary: http://www.djnewsplus.com/access/al?rnd=%2BYKCusNaaL4AsCBmdDKIQA%3D%3D. You can use this link on the day this article is published and the following day.
Publié le 19 novembre 2009 Copyright © 2009 Dowjones
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