Aurobindo Pharma’s wholly owned subsidiary Eugia Pharma Specialties has received the final approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL, 1 mL single dose vial.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug, Pfizer’s Depo-Provera Injectable Suspension. Medroxyprogesterone Acetate Injection is indicated for use by females of reproductive potential to prevent pregnancy, the drugmaker said.
The product will be unveiled in the third quarter of FY23. The approved product has an estimated market size of about $62 million for the 12 months ending June 2022, Aurobindo Pharma said, citing IQVIA numbers.
The pharma major said this was the 147th ANDA, including 10 tentative approvals received, out of Eugia Pharma Speciality Group facilities, manufacturing both oral and sterile specialty products.
Aurobindo shares remained flat, gaining less than 1% on BSE to close at ₹560.35 apiece on Wednesday.
