Zydus Lifesciences has received tentative approval from the USFDA to market Bosentan Tablets for Oral Suspension, 32 mg (reference listed drug: Tracleer®). The drug is indicated for treating pulmonary arterial hypertension (PAH) in pediatric patients aged three and above. Manufactured at Zydus’ Ahmedabad facility, this approval strengthens its US generics portfolio.
Zydus Lifesciences Limited announced that the United States Food and Drug Administration (USFDA) has granted tentative approval for its Bosentan Tablets for Oral Suspension, 32 mg. This generic version of Tracleer® is used to treat pulmonary arterial hypertension (PAH) in children aged three years and older with idiopathic or congenital PAH, helping improve pulmonary vascular resistance (PVR).
The drug will be manufactured at Zydus’ formulation facility in SEZ, Ahmedabad, further expanding the company’s footprint in the US generics market. According to IQVIA data, Bosentan Tablets for Oral Suspension had annual US sales of approximately USD 16 million (as of December 2022), highlighting its commercial potential.
With this approval, Zydus now holds over 340 USFDA approvals and has filed more than 440 ANDAs since FY 2003–04, reinforcing its position as a leading Indian pharmaceutical exporter to the US.
Key Highlights
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Approval: USFDA tentative nod for Bosentan Tablets, 32 mg.
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Indication: Treatment of pulmonary arterial hypertension (PAH) in pediatric patients.
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Manufacturing: Facility located in SEZ, Ahmedabad.
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Market Potential: USD 16 million annual US sales (IQVIA).
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Portfolio Strength: Over 340 USFDA approvals, 440+ ANDA filings.
Sources: Zydus Lifesciences Press Release, PTI Business Report, Northwestern University Research via ScienceDaily