USFDA14 Nov 2025, 01:47 pm
Zydus Lifesciences Receives Final USFDA Approval for Leuprolide Acetate Injection
AI Summary
Zydus Lifesciences Ltd. has received final approval from the USFDA for Leuprolide Acetate injection, 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial. The injection is indicated in the palliative treatment of advanced prostatic cancer and will be manufactured at the Company’s oncology injectable manufacturing facility at SEZ1, Ahmedabad. Leuprolide Acetate injections had annual sales of USD 69 mn in the United States (IQVIA MAT Sept- 2025). Zydus now has 427 approvals and has filed 487 ANDAs since the commencement of the filing process in FY 2003-04.
Key Highlights
- Zydus Lifesciences receives final approval from USFDA for Leuprolide Acetate injection, 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial
- Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer
- The injection will be manufactured at the Company’s oncology injectable manufacturing facility at SEZ1, Ahmedabad
- Leuprolide Acetate injections had annual sales of USD 69 mn in the United States (IQVIA MAT Sept- 2025)
- Zydus now has 427 approvals and has filed 487 ANDAs since the commencement of the filing process in FY 2003-04