Zydus receives USFDA approval for Bosentan 32 mg tablets

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Bosentan tablets, oral suspension, 32 mg (USRLD: Tracleer Tablets for Oral Suspension, 32 mg).

Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension (PAH), specifically to improve exercise ability and reduce clinical worsening in children (aged 3 years and older) with idiopathic or congenital PAH. It is a dual endothelin receptor antagonist that lowers high blood pressure in the lungs, typically administered based on body weight.

Bosentan 32 mg tablets will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad.

Bosentan 32 mg tablets had annual sales of USD 9.3 mn in the United States (IQVIA MAT December 2025).

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