Hyderabad: Aurobindo Pharma Ltd announced that its wholly owned subsidiary, Eugia Pharma Specialties Ltd, has received a final approval from the US Food and Drug Administration (USFDA) to manufacture and market Leuprolide Acetate Injection, 14 mg/2.8 mL MDV (Kit).

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.

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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 Hyderabad-based pharma company said here.

The product is being launched this month and the approved product has an estimated market size of $83 million for the 12 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.

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