Eugia Pharma gets USFDA nod for posaconazole injection, 300 mg/16.7 mL, single-dose vial

Aurobindo Pharma’s wholly owned subsidiary company, Eugia Pharma Specialities, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Posaconazole Injection, 300 mg/16.7 mL (18 mg/mL), Single-Dose Vial, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Noxafil Injection, 300 mg/16.7 mL (18 mg/mL), of Merck Sharp & Dohme LLC (Merck). The product is expected to be launched in December 2023. The approved product has an estimated market size of $ 25.4 million for the twelve months ending October 2023, according to IQVIA.

This is the 173^rd ANDA approval (including eight tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oral and sterile specialty products.

Posaconazole Injection, 300 mg/16.7 mL (18 mg/mL), Single-Dose Vial is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.