Shire Pharmaceuticals said this morning that Canada’s drug regulator is reinstating the marketing authorization for its top-selling ADHD medicine, Adderall XR (amphetamine salts extended release) from August 26, 2005. The drug was suspended from sale in February over concerns that it may have been linked to 20 cases of sudden death [[10/02/05a]], [[15/02/05e]]. Amid the fallout that followed, Shire requested an independent review as part of its appeal against the decision, and this announcement follows the acceptance by Health Canada of the so-called New Drug Committee’ recommendations [[04/03/05c]].
The NDC recommendation for the reinstatement of Adderall XR in Canada, includes revisions to the Canadian Product Monograph and patient leaflet that Shire previously proposed in November 2004. The NDC has also recommended that Shire distribute a ‘Dear Healthcare Professional’ letter and support independent continuing medical education for Canadian physicians to reinforce their understanding of the issues around sudden/cardiac death in the general paediatric population.
Health Canada has agreed to work with Shire to implement the recommendations of the NDC and Shire will work diligently to make Adderall XR available to Canadians in the coming weeks.