Zydus Secures USFDA Approval for Generic PAH Drug Bosentan
Ahmedabad: Zydus Lifesciences Limited has secured final approval from the United States Food and Drug Administration (USFDA) for Bosentan tablets for oral suspension, 32 mg, further strengthening its portfolio in the US generics market.
The approved product is the generic version of Tracleer® Tablets for Oral Suspension, 32 mg (USRLD). Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension (PAH). The drug is specifically used to improve exercise capacity and reduce clinical worsening in children aged three years and older suffering from idiopathic or congenital PAH.
Bosentan is a dual endothelin receptor antagonist that helps lower elevated blood pressure in the lungs. The medicine is generally administered according to body weight, particularly in pediatric patients.
The company stated that the product will be manufactured at its formulation manufacturing facility located in the Special Economic Zone (SEZ), Ahmedabad.
The company stated that the product will be manufactured at its formulation manufacturing facility located in the Special Economic Zone (SEZ), Ahmedabad.
According to IQVIA MAT December 2025 data, Bosentan 32 mg tablets recorded annual sales of approximately USD 9.3 million in the United States.
With this latest approval, Zydus now holds a total of 432 USFDA approvals and has filed 505 Abbreviated New Drug Applications (ANDAs) since it began the filing process in FY 2003-04, as of December 31, 2025.
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