Natco & its alliance partner Lupin receive FDA approval for generic Bosentan Tablets

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Bosentan tablets in the strengths of 62.5 mg and 125 mg. Bosentan is used for the treatment of patients with pulmonary arterial hypertension. The tablets of Natco marketing by its partner Lupin are a generic version of Actelion Pharmaceuticals Ltd’s Tracleer® tablets in the same strengths. As stated by our partner, Lupin, 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.

The release as fetched from its publisher. natcopharma.co.in ↗