Aurobindo Pharma gets USFDA approval for generic antifungal injection

Aurobindo Pharma Ltd on Wednesday said its wholly-owned arm Eugia Pharma Specialities Ltd has received final approval from the US health regulator to manufacture and market generic Posaconazole injection used to prevent serious fungal infections.

The approval by the US Food & Drug Administration (USFDA) is for Posaconazole injection of 300 mg/16.7 mL (18 mg/mL), single-dose vial, Aurobindo Pharma said in a regulatory filing.

It 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), it added.

"The product is expected to be launched in December 2023," the company said.

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 due to certain conditions, it added.

The approved product has an estimated market size of USD 25.4 million for the 12 months ended October 2023, Aurobindo Pharma said citing IQVIA data.