Lupin in alliance with Natco receives FDA approval for Bosentan Tablets

Lupin in alliance with Natco Pharma (Natco) announced that it has received approval for Bosentan Tablets, 62.5 mg and 125 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Actelion Pharmaceuticals Limited’s Tracleer Tablets, 62.5 mg and 125 mg.

Lupin and Natco’s Bosentan Tablets, 62.5 mg and 125 mg, is the generic version of Actelion Pharmaceuticals Limited’s Tracleer Tablets, 62.5 mg and 125 mg. It is indicated for the treatment of pulmonary arterial hypertension in adults to improve exercise ability and to decrease clinical worsening.

Bosentan Tablets, 62.5 mg and 125 mg had an annual sales of approximately USD 84.8 million in the US (IQVIA MAT March 2019).