Zydus Lifesciences Gains USFDA Approval for Eltrombopag Tablets
Filing Summary
Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration for its Eltrombopag Tablets in dosages of 12.5 mg, 25 mg, 50 mg, and 75 mg. These tablets are used to treat thrombocytopenia in specific blood disorders. The product will be manufactured at Zydus’s facility in Ahmedabad. The tablets had annual sales of USD 1263 million in the United States as of November 2025. Zydus has now secured 429 approvals and filed 505 ANDAs since the fiscal year 2003-04.
Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Eltrombopag Tablets in dosages of 12.5 mg, 25 mg, 50 mg, and 75 mg. These tablets are indicated for the treatment of thrombocytopenia, a condition characterized by a low platelet count, in specific blood disorders.
The Eltrombopag Tablets will be produced at Zydus’s formulation manufacturing facility located in SEZ, Ahmedabad. According to IQVIA MAT data from November 2025, the tablets had annual sales of USD 1263 million in the United States.
With this approval, Zydus has now achieved a total of 429 approvals and has filed 505 Abbreviated New Drug Applications (ANDAs) since the commencement of its filing process in the fiscal year 2003-04.
Zydus Lifesciences Limited focuses on the development and manufacturing of pharmaceutical products. The company prioritizes expanding its portfolio of approved drugs and enhancing its manufacturing capabilities to meet global healthcare needs.