Natco Pharma has submitted an Abbreviated New Drug Application (ANDA) with Para IV certification with US Food and Drug Administration (USFDA) for the generic version of Bosentan 32mg tablets for oral suspension. Bosentan 32mg tablets are sold by Actelion Pharmaceuticals US, Inc. (acquired by Johnson & Johnson), under the brand Tracleer.
Tracleer is indicated for the treatment of pulmonary arterial hypertension. As per Johnson & Johnson's annual report, for the year ending 2018, Tracleer had registered sales of around $268 million in the US market, and the 32 mg is one strength that is indicated for pediatric patients.
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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