Natco Pharma receives USFDA’s nod for Bosentan tablets

02 May 2019 Evaluate

Natco Pharma has received final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (USFDA) 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’ Tracleer tablets in the same strengths.

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

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.

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