Zydus Lifesciences bags USFDA nod for prostate cancer drug Apalutamide
Ahmedabad: Pharma major, 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.
Prostate cancer is a common cancer that develops in the prostate gland, which is part of the male reproductive system. It often grows slowly and may not show symptoms in the early stages. When symptoms do appear, they can include difficulty urinating, frequent urination, or blood in the urine. Risk factors include age, family history, ethnicity, and diet. Screening methods like the PSA blood test and digital rectal exam help detect it early.
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).
The group now has 420 approvals and has so far filed 483* ANDAs since the commencement of the filing process in FY 2003-04.
Read also: USFDA nod to Zydus Eluxadoline tablets for irritable bowel syndrome with diarrhoea
Medical Dialogues team had earlier reported that Zydus Lifesciences's wholly owned subsidiary, Zydus Lifesciences Global FZE had entered into an exclusive licensing, supply and commercialization agreement with Zhuhai Beihai Biotech Co., Ltd for BEIZRAY (Albumin Solubilized Docetaxel Injection), a 505(B)(2) product for the US market. BEIZRAY is indicated for the treatment of Breast Cancer, Non-small Cell Lung Cancer, Prostate Cancer, Gastric Adenocarcinoma, and Head and Neck Cancer.
Read also: Zydus inks pact with Beihai Biotech for cancer drug Beizray commercialization in US
Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs.
