Zydus Lifesciences Secures Final USFDA Approval for Apalutamide Tablets

Zydus Lifesciences has achieved a significant milestone by receiving final approval from the US Food and Drug Administration (USFDA) for Apalutamide tablets, 60 mg. Apalutamide is used to treat non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. This approval marks another success for Zydus in the US generics market, following recent approvals for other critical drugs like Enzalutamide and Eluxadoline. The company will manufacture these tablets at its Special Economic Zone (SEZ) facility in Ahmedabad, further strengthening its presence in the global pharmaceutical industry. With this approval, Zydus continues to expand its portfolio of generic drugs, offering affordable treatment options for patients worldwide.

 

Source: Reuters, Business Standard