Shire Pharmaceuticals and Health Canada are to establish an expert panel to review the former’s attention deficit hyperactivity disorder drug, Adderall XR (amphetamine salts extended-release), after the regulator suspended the product’s sales on fears it had been linked to cases of sudden death [[10/02/05a]].
A spokeswoman for Shire told PharmaTimes News Online that the forming such a panel was a standard part of the appeal process. She explained that the panel will comprise three people – one appointed by Shire, one appointed by Health Canada, and a third who will be jointly appointed by the other two members. The panel will assess the situation and pass its recommendations on to Canadian health minister, Ujjal Dosanjh, who will ultimately make recommendations on the drug’s future in Canada. However, the spokeswoman said that there was no way of knowing how long the process would take.
Adderall XR won Canadian approval early last year [[04/02/04d]], and contributed around $10 million dollars to Shire’s coffers in its first year on the market. However, concern has arisen over Shire’s financial performance this coming year after the firm said that growth would ultimately depend on how the US market reacted to the Canadian decision [[03/03/05d]].
