Zydus receives USFDA approval for Leuprolide Acetate injection

Zydus Lifesciences Limited announced it has received final approval from the United States Food and Drug Administration (USFDA) for its Leuprolide Acetate injection, 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial. The approved injection is indicated for the palliative treatment of advanced prostatic cancer and will be manufactured at the company’s oncology injectable manufacturing facility in SEZ1, Ahmedabad.

The Leuprolide Acetate injection generated annual sales of $69 million in the United States, according to IQVIA MAT data as of September 2025. This approval adds to Zydus’s growing portfolio, bringing its total number of approvals to 427.

Since the commencement of its filing process in fiscal year 2003-04, Zydus has filed 487 Abbreviated New Drug Applications (ANDAs) as of September 30, 2025.