Zydus Lifesciences Secures USFDA Approval for Apalutamide Tablets

Zydus Lifesciences Ltd has received USFDA approval to manufacture a generic version of Apalutamide tablets for prostate cancer treatment. The 60 mg tablets will be produced in Ahmedabad, addressing a market with $1,099.8 million annual sales in the US as per IQVIA MAT January 2025 data.

Zydus Lifesciences Ltd has been granted the final nod from the US Food and Drug Administration to manufacture a generic variant of Apalutamide tablets. These are used in the treatment of prostate cancer and mark a significant development in medical treatments for the condition.

The regulatory approval allows Zydus to produce 60 mg strength Apalutamide tablets at its facility in Ahmedabad, India. This development emphasizes the ongoing growth in the pharmaceutical sector, particularly concerning cancer therapies.

Apalutamide, noted as an androgen receptor inhibitor, is prescribed for patients with metastatic castration-sensitive prostate cancer. The economic opportunity is notable, with annual US sales of the drug totaling USD 1,099.8 million, according to IQVIA MAT January 2025 data.

(With inputs from agencies.)