Zydus receives USFDA approval for Leuprolide Acetate injection

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Leuprolide Acetate injection, 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial (USRLD: Lupron Injection, 1 mg/0.2 mL).

Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer.

Leuprolide Acetate injections will be manufactured at the Company's oncology injectable manufacturing facility at SEZ1, Ahmedabad (ALIDAC').

Leuprolide Acetate injection had annual sales of USD 69 mn in the United States (IQVIA MAT Sept 2025).

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