Aurobindo Pharma announced that its wholly owned subsidiary company, Eugia Pharma Specialities, has received a 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, Inc..
The product is expected to be launched by Q4 FY23.
The approved product has an estimated market size of around US$ 145 million for the twelve months ending September 2022, according to IQVIA.
This is a partnership product from TTY Biopharm Company Limited and will be manufactured at their Taiwan facility and marketed by Eugia Pharma.
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