Aurobindo Pharma Limited announced 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 Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL, 1 mL SingleDose Vial. Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL, 1 mL Single-Dose Vial to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Depo-Provera Injectable Suspension, of Pfizer Inc. The product will be launched in Q3 FY23. The approved product has an estimated market size of around US$ 62 million for the twelve months ending June 2022, according to IQVIA.
This is the 147th ANDA (including 10 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
Medroxyprogesterone Acetate Injection is indicated for use by females of reproductive potential to prevent pregnancy.