Eugia Pharma receives USFDA Approval for Leuprolide Acetate Injection
Hyderabad: Aurobindo Pharma Limited is pleased to announce that its wholly owned subsidiary company, Eugia Pharma Specialties Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Leuprolide Acetate Injection, 14 mg/2.8 mL MDV (Kit). Leuprolide Acetate Injection, 14 mg/2.8 mL (1 mg/0.2 mL), Multiple-Dose Vials, to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Lupron Injection, 14 mg/2.8 mL (1 mg/0.2 mL), of AbbVie Endocrinology Inc. (AbbVie). The product is being launched this month. The approved product has an estimated market size of US$ 83 million for the twelve months ending April 2022, according to IQVIA.
This is the 140th ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
Leuprolide Acetate for injection is indicated for the treatment used to treat the symptoms associated with advanced prostate cancer by way of Palliative treatment of advanced prostatic cancer.