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

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.

Read also: Zydus Lifesciences gets USFDA nod for prostate cancer drug Enzalutamide

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