Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (FDA) for bosentan tablets for oral suspension, 32 mg, the company said on Wednesday, February 18.
The approved product is the generic version of Tracleer® tablets for oral suspension, 32 mg, and is indicated for the treatment of pulmonary arterial hypertension (PAH). It is specifically prescribed to improve exercise ability and reduce clinical worsening in children aged three years and above suffering from idiopathic or congenital PAH.
According to the exchange filing, bosentan is a dual endothelin receptor antagonist that helps lower high blood pressure in the lungs and is typically administered based on body weight. The 32 mg tablets for oral suspension will be manufactured at the group’s formulation manufacturing facility located in the SEZ at Ahmedabad.
According to market data from IQVIA (MAT December 2025), bosentan 32 mg tablets recorded annual sales of $9.3 million in the United States, stated the exchange filing.
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With this approval, the group now has 432 approvals and has filed 505 ANDAs since it began the filing process in FY2003-04 (as on December 31, 2025).
Separately, the company launched PEPAIR™, India’s first affordable oscillating positive expiratory pressure (OPEP) device, aimed at improving respiratory health in patients with chronic lung conditions.
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The drug-free, handheld device is designed to aid mucus clearance and enhance breathing in patients suffering from COPD, asthma and bronchiectasis. The device has been priced at ₹990 per unit, positioning it as a cost-effective airway clearance solution.
Shares of Zydus Lifesciences Ltd ended marginally higher on Wednesday, February 18, by 0.65% at ₹912.50 on the NSE.
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