Zydus Lifesciences Gets USFDA Nod for Eltrombopag Tablets

Zydus Lifesciences (

) has received final approval from the US Food and Drug Administration to market Eltrombopag tablets in four dose strengths: 12.5 mg, 25 mg, 50 mg and 75 mg. Eltrombopag is prescribed for thrombocytopenia, a condition of low platelet count seen in certain blood disorders, and acts by stimulating bone marrow cells to boost platelet production and reduce bleeding risk. The product will be manufactured at the company’s SEZ formulation facility in Ahmedabad, underscoring Zydus’s strategy of supplying complex generics to the US from its Indian plants. In the United States, Eltrombopag generated annual sales of about $1,262.5 million as per IQVIA MAT data for November 2025, highlighting a sizeable market opportunity if Zydus can capture even a modest share. With this approval, Zydus’s cumulative USFDA approvals rise to 429, against a total of 505 abbreviated new drug applications (ANDAs) filed since FY2003-04, indicating a strong track record in US generics. Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.