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Mylan (MYL) Gets Approval For Generic Pulmonary Arterial Hypertension Drug

 June 06, 2012 08:14 AM

(By Balaseshan) Mylan Inc. (NASDAQ:MYL), a pharmaceutical company, said its subsidiary received Health Canada approval for generic version of Actelion Pharmaceuticals Ltd.'s pulmonary arterial hypertension drug Tracleer.

Mylan Pharmaceuticals ULC has received approval from Health Canada for Mylan-Bosentan Tablets, 62.5 mg and 125 mg. Mylan-Bosentan is the generic version of Actelion's Tracleer, used for the treatment of pulmonary arterial hypertension.

Pulmonary arterial hypertension is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. The function of the heart and lungs is severely compromised, manifested by a limited exercise capacity, and, ultimately, a reduced life expectancy.

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The first signs of the disease, such as mild shortness of breath, fatigue and difficulty exercising, are so subtle that the disease is often either misdiagnosed or not diagnosed until the patient's condition is far advanced. The survival rate for pulmonary arterial hypertension in untreated patients is only 40% to 55% at two years from the onset of symptoms.

Once patients reach more advanced stages of pulmonary arterial hypertension, they often have no choice but to go on prostacyclin therapy, which requires a 24-hour infusion pump and an intravenous line implanted through the chest directly into the patient's heart. Ultimately, many patients require lung transplantation.

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According to IMS Health, Bosentan Tablets had Canadian sales of about $37.8 million for the twelve months ending March 31, 2012. In Canada, generic drugs cost consumers an average of 60% less than their brand name counterparts.

Currently, Mylan Canada has 38 product applications pending Health Canada approval. These 38 products represent $2.6 billion in annual sales for the 12 months ending March 31, 2012, according to IMS Health.

MYL closed Tuesday's regular session up 0.41% at $20.99. The stock has been trading between $15.49 and $25 for the past 52 weeks.

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