Zydus Lifesciences receives final USFDA approval for Bosentan tablets for oral suspension, 32 mg

Zydus Lifesciences Limited has received final approval from the USFDA for Bosentan tablets, oral suspension, 32 mg (USRLD: Tracleer® Tablets for Oral Suspension, 32 mg). The approval is for the treatment of Pulmonary Arterial Hypertension (PAH) in children aged 3 years and older. The drug is a dual endothelin receptor antagonist that lowers high blood pressure in the lungs, typically administered based on body weight. The group's formulation manufacturing facility at SEZ, Ahmedabad will manufacture the Bosentan 32 mg tablets. The drug had annual sales of USD 9.3 mn in the United States (IQVIA MAT December 2025). Zydus now has 432 approvals and has so far filed 505 ANDAs since the commencement of the filing process in FY 2003-04.