Shire Pharmaceuticals said that Canadian regulators have approved the company’s request to resume marketing Adderall XR in that country.
Health Canada suspended sales of Adderall XR, Shire’s biggest product, in February amid concerns the ADHD drug could cause sudden death in some patients. Shire quickly appealed the decision.
The regulatory agency reversed its decision on the advice of its New Drug Committee, which conducted a review of Adderall, Shire said.
With global sales of $607 million last year, Adderall accounts for more than half of Shire’s total sales and profit.
Following Canada’s withdrawal of Adderall XR, the U.S. FDA worked with Shire to add a warning to the drug’s label not to use it in children or adults with heart defects.
