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Health Canada Requests Safety Data Profiles For ADHD Stimulant Drugs

This article was originally published in The Pink Sheet Daily

Executive Summary

Health Canada requests that manufacturers of stimulants to treat attention deficit/hyperactivity disorder submit "thorough" safety data reviews following the suspension of sales in Canada of Shire's Adderall XR

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Shire Adderall XR Sales Suspended In Canada; FDA Stands By "Black Box"

Company plans a "Dear Doctor" letter informing U.S. physicians of Health Canada's decision. FDA says it "has not decided to take any further regulatory action at this time"; sudden death warnings were added to Adderall XR's labeling in August.

Shire Adderall XR Sales Suspended In Canada; FDA Stands By "Black Box"

Company plans a "Dear Doctor" letter informing U.S. physicians of Health Canada's decision. FDA says it "has not decided to take any further regulatory action at this time"; sudden death warnings were added to Adderall XR's labeling in August.

Shire To Begin Promoting Adderall XR Adult Indication

Adults represent 15%-20% of Adderall XR total scripts, Shire says. The company will be required to submit additional clinical data to receive approval for doses above 30 mg.

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