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Health Canada, the Canadian drug regulatory agency, has suspended the sale of, but not revoked the approval of, Adderall XR in the Canadian market. Adderall XR, made by Shire Pharmaceuticals, is a controlled release amphetamine indicated for the treatment of Attention Deficit Hyper-activity Disorder. The Canadian action was based on U.S. post-marketing reports of sudden deaths in pediatric patients.
The U.S. Food and Drug Administration (FDA) has been in consultation with Health Canada and has issued a statement that, based on current information, it does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug. The agency has …