
New Delhi-based Aurobindo Pharma Ltd announced that its wholly-owned subsidiary, Eugia Pharma Specialities Ltd, has secured final approval from the US Food & Drug Administration (USFDA) for manufacturing and marketing generic Posaconazole injection. The approval covers the 300 mg/16.7 mL (18 mg/mL) single-dose vial, deemed bioequivalent and therapeutically equivalent to Merck's Noxafil Injection. The product, targeted for launch in December 2023, is intended to prevent invasive Aspergillus and Candida infections in severely immunocompromised patients. Aurobindo Pharma estimates a market size of USD 25.4 million based on IQVIA data for the 12 months ending October 2023.
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