Zydus Lifesciences Ltd on Tuesday said it has received final approval from the US health regulator to manufacture a generic version of Apalutamide tablets used in the treatment of prostate cancer. The approval by the US Food and Drug Administration (USFDA) is to manufacture Apalutamide tablets of 60 mg strength, Zydus Lifesciences said in a regulatory filing.
The approved Apalutamide tablets will be produced at Zydus Lifesciences (SEZ), Ahmedabad, it added.
Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer.
It had annual sales of USD 1,099.8 million in the US, the company said, citing IQVIA MAT January 2025 data.
