Natco, Lupin receive USFDA approval for Bosentan tablet

Natco Pharma has announced that along with its alliance partner Lupin, the company has received final approval of ANDA for generic Bosentan tablets, 62.5 mg and 125 mg.

The Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (USFDA) for Bosentan tablets of 62.5 mg and 125 mg. The drug is a generic version of Actelion Pharmaceuticals' Tracleer tablets available in the same strength.

Bosentan is a dual endothelin receptor antagonist indicated for the treatment of Pulmonary Arterial Hypertension (PAH) in adults to increase their ability to exercise and to decrease clinical worsening.

According to IQVIA MAT March 2019 data, Bosentan tablets 62.5 mg and 125 mg registered sales of around US$ 84.8 million per annum in the US market. The drug will be marketing in the US by Lupin, who is Natco's marketing partner.

On Thursday, during lunch hours, the stock of Lupin was trading at Rs. 878.00 per share, up by Rs. 7.30 or 0.84 per cent, while Natco Pharma was quoting Rs. 539.15 per share, Rs. 5.00 or 0.92 per cent on BSE.