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Eugia Pharma Specialities Ltd Gets USFDA Final Approval for Posaconazole Injection
Aurobindo Pharma Limited's wholly owned subsidiary company, Eugia Pharma Specialities Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Posaconazole Injection, 300 mg/16.7 mL (18 mg/mL), Single-Dose Vial, which 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).
The product is expected to be launched in December 2023. The approved product has an estimated market size of USD 25.4 million for the twelve months ending October 2023, according to IQVIA.
This is the 173rd ANDA approval (including 8 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oral and sterile specialty products.Posaconazole Injection, 300 mg/16.7 mL (18 mg/mL), Single-Dose Vial is indicated forthe prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versushost disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
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