Zydus Lifesciences gets USFDA nod for generic blood disorder drug

Zydus Lifesciences has secured final approval from the USFDA for its generic Eltrombopag tablets. These tablets treat low platelet counts in specific blood disorders. The approval covers multiple strengths. Production will occur at the company's A...

By PTI | Updated: Jan 15, 2026, 03.32 PM IST

New Delhi, Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator for its generic version of Eltrombopag tablets, indicated for the treatment of thrombocytopenia (low platelet count) in specific blood disorders.

The final approval granted by the US Food and Drug Administration (USFDA) is for Eltrombopag tablets in strengths 12.5 mg, 25 mg, 50 mg, and 75 mg, Zydus Lifesciences said in a regulatory filing.

Eltrombopag tablets will be produced at the group's formulation manufacturing facility at SEZ, Ahmedabad, it added.

The tablets are indicated for the treatment of thrombocytopenia (low platelet count) in specific blood disorders. It works by stimulating bone marrow cells to produce more platelets, thereby reducing the risk of bleeding, the company said.

Citing IQVIA MAT November 2025 data, the company said Eltrombopag tablets had annual sales of USD 1,262.5 million in the US.

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