Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) for Eltrombopag Tablets in strengths of 12.5 mg, 25 mg, 50 mg, and 75 mg. These tablets are indicated for the treatment of thrombocytopenia (low platelet count) in specific blood disorders. Eltrombopag works by stimulating bone marrow cells to produce more platelets, reducing the risk of bleeding. The annual sales for these tablets were USD 1262.5 mn.
USFDA Approval for Eltrombopag Tablets
Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Eltrombopag Tablets. The approval covers strengths of 12.5 mg, 25 mg, 50 mg, and 75 mg. This announcement was made on January 15, 2026.
Therapeutic Indication and Mechanism
Eltrombopag tablets are indicated for treating thrombocytopenia (low platelet count) in specific blood disorders. The medication functions by stimulating bone marrow cells to increase platelet production, thereby reducing the risk of bleeding in affected patients.
Manufacturing and Market Data
The Eltrombopag tablets will be manufactured at Zydus’s formulation manufacturing facility located at SEZ, Ahmedabad. According to IQVIA data as of November 2025, Eltrombopag tablets had annual sales of USD 1262.5 mn in the United States.
ANDA Filings and Approvals
As of the announcement, Zydus Lifesciences has 429 approvals and has filed 505 ANDAs since the commencement of its filing process in FY 2003-04.
Source: BSE
