Zydus Lifesciences receives USFDA approval for Apalutamide Tablets, 60 mg

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Apalutamide Tablets, 60 mg (Erleada Tablets, 60 mg).

Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer.

Apalutamide tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad.

Apalutamide tablets had annual sales of USD 1099.8 mn in the United States (IQVIA MAT January 2025).

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