Zydus Lifesciences bags tentative USFDA nod for Enzalutamide Tablets for prostate cancer

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-10-02T21:38:02+05:30 | Updated On 2 Oct 2024 9:38 PM IST

Ahmedabad: Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) to manufacture Enzalutamide Tablets, 40 mg and 80 mg (USRLD: Xtandi Tablets, 40 mg, 80 mg).

Enzalutamide tablets are androgen receptor inhibitors indicated for the treatment of patients with castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.

Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad.

Enzalutamide tablets, 40 mg and 80 mg had annual sales of USD 1417.2 mn in the United States (IQVIA MAT July 2024).

The group now has 400 approvals and has so far filed over 465* ANDAs since the commencement of the filing process in FY 2003-04.

Medical Dialogues team had earlier reported that the Company had received received final approval from the USFDA to manufacture Enzalutamide Capsules, 40 mg for the treatment of patients with metastatic castration-resistant prostate cancer.

Zydus Lifesciences Ltd. is an innovative, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Zydus has been actively discovering and developing New Chemical Entities (NCEs) novel biologicals, several biosimilars and vaccines as a part of its innovation pipeline. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars

zydus Lifescienceszydus Lifesciences newsUSFDAEnzalutamide TabletsXtandi Tabletsprostate cancer

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-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