Aurobindo Pharma’s wholly owned subsidiary company -- Eugia Pharma Specialties 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 $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.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
