Zydus Life gets FDA nod for children's lung treatment drug bosentan

• Zydus Lifesciences Ltd received final FDA approval for bosentan tablets for oral suspension, 32 mg, on February 18.
• The drug is a generic version of Tracleer® and treats pulmonary arterial hypertension (PAH) in children aged three and above.
• Bosentan is a dual endothelin receptor antagonist, lowering high blood pressure in the lungs, manufactured in Ahmedabad.
• Bosentan 32 mg tablets recorded annual sales of $9.3 million in the US (MAT December 2025).
• Zydus also launched PEPAIR™, India's first affordable oscillating positive expiratory pressure (OPEP) device for chronic lung conditions.