Shire to review options after US SPD465 delay
UK drugmaker Shire has received an "approvable" letter from the US Food and Drug Administration for SPD465 (triple-bead mixed amphetamine salts), an investigational oral stimulant intended to provide symptom control of attention-deficit hyperactivity disorder in adults for up to 16 hours with one daily dose.
The conditions of the approvable letter were not revealed but a Shire press release noted that, following receipt of the letter, the firm is evaluating its options related to SPD465. Shire submitted a New Drug Application for SPD465 on July 21, 2006. If approved, the product will be a treatment option for adults with ADHD and part of Shire's most lucrative portfolio.
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