Hyderabad-based Natco Pharma gets FDA approval for marketing Bosentan Tablets in the United States

Hyderabad based Natco pharma and its associate Lupin Limited got yet another US FDA approval for manufacture of Bosentan tablets

Hyderabad: Global pharma major Lupin Limited (Lupin) and its alliance partner Natco Pharma Limited (Natco) have announced that they received the 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. The approval will enable the company to market a generic equivalent of Tracleer Tablets for Oral Suspension of Actelion Pharmaceuticals US, Inc.

The company press release said Natco is the exclusive first-to-file for this product and is eligible for 180 days exclusivity.

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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 United States.