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  • Zydus Lifesciences...

Zydus Lifesciences bags USFDA nod for prostate cancer drug Apalutamide

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-03-19T11:30:00+05:30  |  Updated On 19 March 2025 11:30 AM IST
Lalitpur Pharma Park
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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.

Read also: CDSCO Panel suggests revising phase III CT protocol of Zydus Healthcare's Empagliflozin plus Metoprolol Succinate FDC

zydus lifescienceszydus lifescinces newsUSFDAapalutamideprostate cancer
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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