Zydus Lifesciences Ltd has received final approval from the US Food and Drug Administration (USFDA) for its generic Leuprolide Acetate injection, used for the palliative management of advanced prostatic cancer.
The approval covers Leuprolide Acetate injection in the 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial format, referencing the listed drug Lupron Injection (1 mg/0.2 mL). The product will be manufactured at the company’s oncology injectable facility located in SEZ-1, Ahmedabad.
Leuprolide Acetate is widely used to alleviate symptoms in patients with advanced prostate cancer. According to IQVIA MAT September 2025 data, the product recorded annual US sales of approximately USD 69 million.
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