Zydus Lifesciences Gains USFDA Nod for Generic Cancer Treatment

Zydus Lifesciences Ltd has obtained USFDA approval for a generic version of Leuprolide Acetate injection, used in treating advanced prostatic cancer. The product will be manufactured in Ahmedabad and targets a market with annual sales of USD 69 million in the US.

Zydus Lifesciences Ltd has announced its receipt of final approval from the US Food and Drug Administration (USFDA) for its generic formulation of Leuprolide Acetate injection. This drug is used in the palliative treatment of advanced prostatic cancer, a significant milestone for the generic pharmaceutical company.

The USFDA's approval covers Leuprolide Acetate injection with strengths of 14 mg/2.8 ml (1 mg/0.2 mL) in a multiple-dose vial format. This is in reference to the already existing Lupron Injection on the market.

Zydus anticipates manufacturing these injections at its oncology facility located in SEZ1, Ahmedabad, India. Citing IQVIA MAT data from September 2025, the company noted that the product achieves annual U.S. sales of USD 69 million, highlighting its market potential.

(With inputs from agencies.)