Lupin and Natco receives USFDA approval for Bosentan Tablets for Oral Suspension

Used in treatment of pulmonary arterial hypertension in pediatric patients

Lupin and its alliance partner Natco Pharma Limited (Natco), today announced that they have received an approval from the United States Food and Drug Administration (U.S. FDA) for Natco's Abbreviated New Drug Application (ANDA) for Bosentan Tablets for Oral Suspension, 32 mg, to market a generic equivalent of Tracleer Tablets for Oral Suspension of Actelion Pharmaceuticals US, Inc. Natco is the exclusive first-to-file for this product and is eligible for 180 days exclusivity.

Bosentan Tablets for Oral Suspension are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.

Bosentan Tablets for Oral Suspension (RLD Tracleer) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT December 2024).

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