Zydus Secures Final Nod From FDA For Generic Blood Disorder Drug Eltrombopag

Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (USFDA) for its generic version of Eltrombopag tablets, a medicine used in the treatment of thrombocytopenia, a condition characterised by low platelet counts associated with certain blood disorders.

The regulatory clearance covers four strengths of the drug — 12.5 mg, 25 mg, 50 mg and 75 mg — enabling the company to market these products in the US. 

Eltrombopag works by stimulating bone marrow to increase platelet production, helping reduce the risk of bleeding in patients with low platelet counts. The tablets are slated to be manufactured at Zydus’ formulation facility in SEZ Ahmedabad. 

The company noted that the Eltrombopag segment had annual sales of about USD 1.26 billion in the United States as of November 2025, highlighting the commercial significance of this approval. 

This milestone adds to Zydus’ growing portfolio of USFDA‑approved products, reinforcing its presence in the world’s largest generics market.

With the final approval secured, Zydus is now positioned to launch and commercialise its generic Eltrombopag tablets in the United States, potentially expanding access to more affordable treatment options for patients and strengthening its revenue base in regulated markets.

Also Read