Aurobindo Pharma arm copy of Pfizer’s drug gets U.S. FDA nod

Aurobindo Pharma subsidiary Eugia Pharma Specialties has received the final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Carboprost Tromethamine Injection USP 250 mcg/mL, single-dose vials.

Bioequivalent and therapeutically equivalent to Pfizer’s Hemabate Injection, 250mcg/mL, the reference listed drug, it is expected to be introduced in June. The approved product has an estimated market size of about $51.4 million for the 12 months ending March 2023, Aurobindo said citing IQVIA numbers.

The product is indicated for aborting pregnancy between the 13th and 20th weeks of gestation and for the treatment of postpartum haemorrhage due to uterine atony. This is the 159th approved ANDA, including eight tentative approvals received, out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products, the company said.

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