Archive · 15 Jan 2026
Zydus Lifesciences gets US FDA approval for Eltrombopag Tablets
Zydus Lifesciences, an Indian company, got permission from the US FDA to sell Eltrombopag Tablets.
These tablets help people who have low platelet counts because of certain blood problems.
The tablets come in four different strengths and will be made in Ahmedabad, India.
In the US, this medicine sold $1.26 billion in 2025.
This is Zydus's 429th approval from the US FDA.
They have asked for 505 approvals since they started in 2003-04.
The company's shares went down a little the day before this news.
Zydus Lifesciences received final US FDA approval for Eltrombopag Tablets in four strengths.
The drug treats thrombocytopenia by stimulating bone marrow to increase platelet production.
Tablets will be manufactured at Zydus's Ahmedabad facility.
Eltrombopag recorded $1.26 billion in US sales for 2025.
This approval brings Zydus's total USFDA approvals to 429 out of 505 filed ANDAs.
- Who
- Zydus Lifesciences Ltd.
- What
- Received final approval from the US FDA for Eltrombopag Tablets
- When
- January 15
- Where
- United States (approval), Ahmedabad (manufacturing)
- Why
- To treat thrombocytopenia (low platelet count) associated with certain blood disorders
- Company
- Zydus Lifesciences Ltd.
- Approval Date
- January 15
- Regulatory Body
- US Food and Drug Administration
- Drug Name
- Eltrombopag Tablets
- Strengths Approved
- 12.5 mg, 25 mg, 50 mg, 75 mg
- Manufacturing Location
- Ahmedabad, India
- US Market Sales (2025)
- $1,262.5 million
- Cumulative USFDA Approvals
- 429
- Total ANDAs Filed
- 505