Archive · 24 Jul 2025
Zydus Receives Tentative USFDA Approval For Cancer Drug
Zydus Lifesciences, a company, got a temporary OK from the US government to sell a cheaper version of a blood cancer medicine called Ibrutinib.
This means they can start selling it in the US, but maybe not right away.
The medicine helps adults with different blood cancers like Chronic lymphocytic leukaemia and Waldenstrom's macroglobulinemia.
The pills will be made in Ahmedabad.
The original medicine sold for over two billion dollars in the US recently, showing there is a need for this drug.
Zydus Lifesciences received tentative approval from the USFDA.
The approval is for a generic version of Ibrutinib tablets.
Ibrutinib tablets are used to treat various blood cancers.
The tablets will be produced at Zydus Lifesciences Ltd SEZ in Ahmedabad.
Ibrutinib tablets had USD 2148.9 million in annual sales in the US in May 2025.
- Who
- Zydus Lifesciences and USFDA.
- What
- Zydus Lifesciences received tentative approval for generic Ibrutinib tablets.
- When
- Thursday (unspecified date).
- Where
- US (for sales); Ahmedabad (for manufacturing).
- Why
- To provide a generic version of a cancer treatment drug.
- Company
- Zydus Lifesciences
- Regulatory Agency
- USFDA
- Drug Name
- Ibrutinib tablets
- Indication
- Treatment of blood cancers
- Production Location
- Zydus Lifesciences Ltd SEZ, Ahmedabad
- Annual Sales (USD)
- 2148.9 million (MAT May 2025)