Aurobindo Pharma Ltd, on 27 December, announced that its wholly-owned arm Eugia Pharma Specialities Ltd had received final approval from the USFDA (US Food and Drug Administration) for antifungal injections.

In its regulatory filing, the company said that Eugia Pharma Specialities Ltd has received final approval to manufacture and market Posaconazole injection of 300 mg/16.7 mL (18 mg/mL), a single-dose vial, which is used to prevent serious fungal infections.

The drug is a bioequivalent to the RLD (reference listed drug) Noxafil Injection, 300 mg/16.7 mL (18 mg/mL), of Merck Sharp & Dohme LLC.

The company said that the injections are set to launch in December 2023.

The Posaconazole injection, 300 mg/16.7 mL (18 mg/mL), single-dose vial is used for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections caused by being severely immunocompromised.

The Posaconazole injection has an estimated market size of $25.4 million for the 12 months ended October 2023, according to the IQVIA data.