USFDA2 Oct 2024, 05:50 pm
Zydus Lifesciences Ltd Receives Tentative Approval from USFDA for Enzalutamide Tablets
AI Summary
Zydus Lifesciences Ltd has announced that it has received tentative approval from the USFDA to manufacture Enzalutamide Tablets, 40 mg and 80 mg. The tablets are androgen receptor inhibitors indicated for the treatment of patients with castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. The group's manufacturing site at SEZ, Ahmedabad will produce these tablets. Enzalutamide tablets, 40 mg and 80 mg had annual sales of USD 1417.2 mn in the United States (IOVIA MAT July 2024). As of 30th June 2024, the group has 400 approvals and has filed over 465 ANDAs since the commencement of the filing process in FY 2003-04.
Key Highlights
- Zydus Lifesciences Ltd receives tentative approval from USFDA for Enzalutamide Tablets, 40 mg and 80 mg
- The tablets are androgen receptor inhibitors for the treatment of prostate cancer
- The manufacturing will be done 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 (IOVIA MAT July 2024)
- Zydus Lifesciences Ltd has 400 approvals and has filed over 465 ANDAs since FY 2003-04