Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) for its generic version of Leuprolide Acetate injection, in a 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial format. The product is a generic equivalent of Lupron Injection and is indicated for the palliative treatment of advanced prostate cancer.

The approved injection will be manufactured at Zydus’s oncology injectable facility at SEZ-1 in Ahmedabad. According to IQVIA data for the year to September 2025, the US market for the reference drug had annual sales of around USD 69 million.

This approval marks a significant milestone for Zydus as it strengthens its presence in the highly regulated US oncology injectable market and reflects the company’s manufacturing capabilities in complex generics.