25 June 2019 - - Israeli generics company Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) (TASE: TEVA) has launched a generic version of Tracleer1 (bosentan) tablets, 62.5 mg and 125 mg, in the US, the company said.
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.
With nearly 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the US Currently, one in nine generic prescriptions dispensed in the US is filled with a Teva generic product.
Bosentan Tablets are indicated for the treatment of pulmonary arterial hypertension (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, PAH associated with connective tissue diseases, and PAH associated with congenital heart disease with left-to-right shunts.