Zydus Lifesciences gets USFDA nod for Leuprolide Acetate injection

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator for its generic version of Leuprolide Acetate injection used in palliative treatment of advanced prostatic cancer.

The approval by the US Food and Drug Administration (USFDA) is for Leuprolide Acetate injection of strengths 14 mg/2.8 ml (1 mg/0.2 mL) multiple-dose vial (reference listed drug Lupron Injection, 1 mg/0.2 mL), Zydus Lifesciences said in a regulatory filing.

The Leuprolide Acetate injections will be manufactured at the company's oncology injectable manufacturing facility at SEZ1, Ahmedabad, it added.


Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer. It had annual sales of USD 69 million in the US, the company said citing IQVIA MAT September 2025 data.