Health Canada approves Mylan-Rosuvastatin Calcium Tablets

Mylan Pharmaceuticals ULC, the Canadian subsidiary of Mylan Inc. (NASDAQ: MYL), today received approval from Health Canada for Mylan-Rosuvastatin Calcium Tablets, 5mg, 10mg, 20mg and 40mg. Mylan-Rosuvastatin is the generic version of Astra Zeneca's Crestor® Tablets, which are used for the management of primary hypercholesterolaemia, mixed dyslipidaemia, and familial hypercholesterolaemia.  According to IMS Health, Rosuvastatin Calcium Tablets, 5mg, 10mg, 20mg and 40mg, had Canadian sales of approximately $742 million for the 12 months ending Dec. 31, 2011.

"We are very pleased to introduce Mylan-Rosuvastatin to the Canadian market," said Dick Guest, president of Mylan Canada. "According to the Canadian Heart and Stroke Foundation, 'about 40% of Canadians have high blood cholesterol.' Not only does this introduction provide Canadians with access to our quality medicine, it does so at a substantially lower cost. The introduction of generic medicines like Mylan-Rosuvastatin helps to contribute to a sustainable health care system."

Currently, Mylan Canada has 42 product applications pending Health Canada approval representing $3.6 billion in annual sales, according to IMS Health.

In Canada, generic drugs cost consumers an average of 60% less than their brand name counterparts. 

Mylan-Rosuvastatin is contraindicated in patients who are hypersensitive to it and in patients with active liver disease.  Pregnant women or women wishing to become pregnant should not take Rosuvastatin, as well as patients taking cyclosporine.