Aurobindo Pharma's Subsidiary Receives USFDA Approval for Posaconazole Injection

27 Dec 2023 , 03:02 PM

Aurobindo Pharma Ltd’s subsidiary, Eugia Pharma Specialities Ltd, secures final approval from the USFDA for manufacturing and marketing Posaconazole Injection.

The approved product, bioequivalent to Merck Sharp & Dohme LLC’s Noxafil Injection, is in the strength of 300 mg/16.7 mL (18 mg/mL), Single-Dose Vial.

The launch of the product is scheduled for December 2023, targeting an estimated market size of US$ 25.4 million for the 12 months ending October 2023, according to IQVIA.

This approval marks the 173rd ANDA approval from Eugia Pharma Specialities Group (EPSG), which specializes in manufacturing both oral and sterile specialty products.

Posaconazole Injection is indicated for prophylaxis against invasive Aspergillus and Candida infections in severely immunocompromised patients, including hematopoietic stem cell transplant recipients with graft-versus-host disease and those with hematologic malignancies undergoing chemotherapy-induced prolonged neutropenia.

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