Last Updated on December 24, 2023 by The Health Master
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.
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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