Teva Pharmaceutical Industries Ltd. has announced the launch of a generic version of Tracleer® (bosentan) tablets, 62.5 mg and 125 mg, in the U.S.

Bosentan Tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) in adults to improve exercise ability and to decrease worsening of the condition. PAH is high blood pressure in the blood vessels of the lungs. Due to the risks of liver damage, and serious birth defects, Bosentan Tablets are available only through a restricted distribution program called the Bosentan REMS Program.

Brendan O’Grady, EVP and Head of North America Commercial said, “The launch of Bosentan Tablets in the U.S. is an important addition to Teva’s generics portfolio. The exact cause of PAH is unknown with no known cure. We are proud to offer another generic treatment option to patients living with this chronic condition.”

Bosentan Tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%).