Aurobindo Pharma subsidiary Eugia Pharma Specialties has acquired the ultimate approval from the U.S. Food and Drug Administration (U.S. FDA) to fabricate and market Carboprost Tromethamine Injection USP 250 mcg/mL, single-dose vials.
Bioequivalent and therapeutically equal to Pfizer’s Hemabate Injection, 250mcg/mL, the reference listed drug, it’s anticipated to be launched in June. The permitted product has an estimated market measurement of about $51.4 million for the 12 months ending March 2023, Aurobindo mentioned citing IQVIA numbers.
The product is indicated for aborting being pregnant between the thirteenth and twentieth weeks of gestation and for the therapy of postpartum haemorrhage attributable to uterine atony. This is the 159th permitted ANDA, together with eight tentative approvals acquired, out of Eugia Pharma Specialty Group (EPSG) services, manufacturing each oral and sterile specialty merchandise, the corporate mentioned.
