Aurobindo Pharma has announced that its wholly-owned subsidiary company, Eugia Pharma Specialities, has received final approval from the US Food & Drug Administration (USFDA) for Amphotericin B Liposome for Injection, 50 mg.

Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), AmBisome Liposome for Injection, 50 mg/vial, of Astellas Pharma US.

The product is expected to be launched by Q4 FY23 and the approved product has an estimated market size of around $145 million for the twelve months ending September 2022, according to IQVIA, the company said.

This is a partnership product from TTY Biopharm Company and will be manufactured at their Taiwan facility and marketed by Eugia Pharma.

This is the 152nd ANDA (including 10 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile speciality products.