Hyderabad, India-headquartered Aurobindo Pharma announced that its wholly- owned subsidiary Eugia Pharma Specialties, received final approval from the U.S. Food & Drug Administration to manufacture and market Leuprolide Acetate injection, 14 mg/2.8 mL MDV (Kit). This drug is indicated for the palliative treatment of advanced prostate cancer.
The product is therapeutically equivalent to the reference listed drug product, Lupron Injection of AbbVie Endocrinology, and will be presented as multiple-dose vials according to the company.
According to Danbury, CT-based IQVIA, global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, the approved product had an estimated market size of $83 million for the twelve months ending April 2022.
This is the 140th abbreviated new drug application, (including eight tentative approvals received), from the Eugia Pharma Specialty Group, which manufactures both oral and sterile specialty products.
Last updated: December 26th, 2025
