Zydus receives USFDA approval for Leuprolide Acetate injection Back
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). <p> Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer. <p> Leuprolide Acetate injections will be manufactured at the Company's oncology injectable manufacturing facility at SEZ1, Ahmedabad (‘ALIDAC'). <p> Leuprolide Acetate injection had annual sales of USD 69 mn in the United States (IQVIA MAT Sept 2025).