Shire receives US FDA approvable letter for ADHD treatment INTUNIV |
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Published
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Thu, 21 Jun 2007 07:51
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LONDON (Thomson Financial) - Specialty biopharmaceutical company Shire PLC said it received an approvable letter from the US Food and Drug Administration for its nonstimulant treatment for attention-deficit/hyperactivity disorder (ADHD), INTUNIV.The company said the information requested by the FDA was not unexpected and that Shire is working with the FDA to provide a full and timely response to the agency's request.An approvable letter indicates that FDA is prepared to approve the application upon the satisfaction of conditions specified in the approvable letter. Drug products which are the subject of approvable letters may not be legally marketed until the firm has satisfied the identified deficiencies.TFN.newsdesk@thomson.comrda/jsaCOPYRIGHTCopyright AFX News Limited 2007. All rights reserved.The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News.
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Shire stimulant SPD465 gets FDA approvable letter; evaluating options 