Zydus Lifesciences Limited 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, sold under the brand name Erleada among others, is a nonsteroidal antiandrogen (NSAA) medication used for the treatment of prostate cancer. It is an androgen receptor inhibitor. It is taken by mouth. Apalutamide was first described in 2007, and was approved for the treatment of prostate cancer in February 2018. It is the first medication to be approved specifically for the treatment of non-metastatic castration-resistant prostate cancer.
Apalutamide tablets had annual sales of USD 1099.8 mn in the United States (IQVIA MAT January 2025).
