Mylan Pharmaceuticals, the Canadian subsidiary of Mylan, has gained Health Canada approval for Mylan-Bosentan Tablets, 62.5mg and 125mg.
The generic version of Actelion's Tracleer is indicated for pulmonary arterial hypertension.
Mylan Canada president and CEO Dick Guest said, "By providing access to more affordable generic drugs, Mylan helps to reduce the burden on our health care system, benefiting all Canadians."
Bosentan Tablets had Canadian sales of approximately $37.8m for the 12 months ending 31 March 2012, according to IMS Health.
Mylan Canada at present has 38 product applications pending Health Canada approval.
In Canada, generic drugs cost consumers an average of 60% less than their brand name counterparts, according to the company.
