Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Enzalutamide Capsules, 40 mg. These capsules are used in the treatment of metastatic castration-resistant prostate cancer as androgen receptor inhibitors. The approved medication is the generic version of Xtandi® Capsules.
The Enzalutamide Capsules will be manufactured at Zydus’ facility in Moraiya, Ahmedabad. The product has significant market potential, with annual sales of approximately $869.4 million in the United States as of July 2024, according to IQVIA data.
This approval marks an important milestone for Zydus, bringing their total USFDA approvals to 400. The company has also filed over 465 Abbreviated New Drug Applications (ANDAs) since they began the process in the 2003-04 financial year.
The shares ended 0.53% higher at ₹1,073.65 on NSE (Friday 3:30 PM).
