Lupin-Natco get USFDA nod to market generic hypertension drug

Drug firm Lupin, in alliance with Natco Pharma, has received approval from the US health regulator to market generic Bosentan tablets used for treatment of pulmonary arterial hypertension, the Mumbai-based company said Tuesday.

The approval by the United States Food and Drug Administration (USFDA) is for marketing Bosentan tablets in the strengths of 62.5 mg and 125 mg, Lupin said in a statement.

The tablets of Lupin and Natco are generic version of Actelion Pharmaceuticals Ltd's Tracleer tablets in the same strengths, it added.

As per IQVIA MAT March 2019 data, Bosentan tablets 62.5 mg and 125 mg had an annual sales of around USD 84.8 million in the US market, Lupin said.

The tablets are indicated for the treatment of pulmonary arterial hypertension in adults to improve exercise ability and to decrease clinical worsening.

Shares of Lupin Ltd closed at Rs 867.65 per scrip on the BSE, down 0.07 per cent from its previous close.