Zydus Lifesciences gets USFDA nod for prostate cancer drug Enzalutamide
Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Enzalutamide Capsules, 40 mg (USRLD: Xtandi Capsules, 40 mg).
Enzalutamide capsules are androgen receptor inhibitors indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
Metastatic castration-resistant prostate cancer (mCRPC) is an advanced form of prostate cancer that has spread beyond the prostate gland to other parts of the body, such as the bones or lymph nodes, and continues to progress despite hormone therapies that lower testosterone levels. Patients often experience symptoms like bone pain, fatigue, and weight loss. mCRPC is generally aggressive, with varying prognoses depending on individual health and response to treatment, necessitating a multidisciplinary approach for effective management.
Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad.
Enzalutamide capsules, 40 mg had annual sales of USD 869.4 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.
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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.
