Shire Announces Suspension of ADDERALL XR(R) Sales in Canada

Press Release:

Shire Announces Suspension of ADDERALL XR(R) Sales in Canada

Press Release
News Article February 2005

BASINGSTOKE, England and PHILADELPHIA, Pennsylvania, February 10/PRNewswire-FirstCall/ -- Shire Pharmaceuticals Group plc announces that Health Canada has requested the suspension of sales of Shire's attention deficit hyperactivity disorder (ADHD) treatment, ADDERALL XR(R) in Canada following Health Canada's interpretation of adverse event data as part of routine label updating.

Although Shire is complying with this request the Company strongly disagrees with the conclusions drawn by Health Canada and is considering appropriate responsive action.

Matthew Emmens, Chief Executive Officer, commented:

"We are surprised by this action from Health Canada. Shire remains confident in the safety and efficacy of ADDERALL XR."

The marketing and availability of ADDERALL XR in the United States is unaffected. Shire remains confident in the safety and effectiveness of this drug for the treatment of ADHD when used in accordance with the approved labeling.

ADDERALL XR was approved by Health Canada on January 21, 2004 and launched in February 2004. Approximately 11,000 patients are currently prescribed ADDERALL XR in Canada. ADDERALL XR contributed around US $10m of Shire's annual revenue in its first year on the Canadian market.

The labeling updating with Health Canada was part of Shire's regular ongoing process of revising the product label with information gathered during the lifetime of the drug.

The interpretation of the same data by the US FDA led to a revised US label for ADDERALL XR in September 2004, clarifying that the drug generally should not be used in children or adults with structural cardiac abnormalities.

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