LONDON (Thomson Financial) - Shire PLC said it has received an approvable letter from the US Food and Drug Administration for an investigational oral stimulant, SPD465, intended to provide symptom control of attention deficit hyperactivity disorder (ADHD) in adults for up to 16 hours with one daily dose.
Shire said it is evaluating its options related to SPD465 (triple-bead mixed amphetamine salts) following receipt of this approvable letter.
Shire submitted a New Drug Application for SPD465 in July last year and, if approved, it would be come part of Shire's overall ADHD portfolio which includes stimulant VYVANSE, which is planned to launch in the second quarter. tf.TFN-Europe_newsdesk@thomson.com hjp COPYRIGHT Copyright 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.
Shire said it is evaluating its options related to SPD465 (triple-bead mixed amphetamine salts) following receipt of this approvable letter.
Shire submitted a New Drug Application for SPD465 in July last year and, if approved, it would be come part of Shire's overall ADHD portfolio which includes stimulant VYVANSE, which is planned to launch in the second quarter. tf.TFN-Europe_newsdesk@thomson.com hjp COPYRIGHT Copyright 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.