Zydus Lifesciences gets USFDA nod for generic blood disorder drug
- IBEF
- January 16, 2026
Zydus Lifesciences Ltd has received final approval from the US Food and Drug Administration (USFDA) for its generic version of Eltrombopag tablets, according to a regulatory filing. The approval covers multiple dosage strengths, 12.5 mg, 25 mg, 50 mg, and 75 mg, and enables the company to market and distribute the product in the United States, one of the world’s largest pharmaceutical markets. Eltrombopag tablets are prescribed for the treatment of thrombocytopenia, a condition characterised by low platelet counts associated with certain blood disorders. The approval marks another addition to Zydus Lifesciences’ expanding portfolio of USFDA-approved generic medicines, underscoring the company’s continued focus on regulated markets and its commitment to developing products that meet stringent global regulatory standards.
The company stated that the approved tablets will be manufactured at its formulation facility located in the Special Economic Zone (SEZ) at Ahmedabad, supporting its export-oriented pharmaceutical operations. As per IQVIA MAT November 2025 data cited in the regulatory filing, Eltrombopag tablets recorded annual sales of Rs. 10,480 crore (US$ 1.26 billion) in the US market, underscoring the commercial significance of the product. The approval adds to Zydus Lifesciences’ growing portfolio of USFDA-approved products and strengthens its presence in the regulated generics segment. The company noted that the clearance reinforces its focus on complex and specialty generics while enhancing its ability to address demand in key international markets, particularly the United States.
Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.
Partners
