18 Feb 2026 | 5 Mins Read

Zydus Life receives FDA approval for bosentan children's lung treatment

Flipitmoney

Zydus Lifesciences Ltd received final approval from the US FDA for bosentan tablets, a generic version of Tracleer, for treating pulmonary arterial hypertension in children aged 3 and above. Manufactured at Ahmedabad, the 32 mg tablets recorded $9.3 million annual sales in the US. This brings the company's total USFDA approvals to 432 and ANDAs filed to 505.