Aurobindo Pharma Secures USFDA Nod For Generic Antifungal Injection

Aurobindo Pharma Ltd said that its wholly-owned subsidiary, Eugia Pharma Specialities Ltd, has acquired final permission from the US Food and Drug Administration to manufacture and market generic Posaconazole injection, which is used to prevent dangerous 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, as per economic times.

"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 suggested for the prevention of invasive Aspergillus and Candida infections in individuals who are severely immunocompromised due to certain circumstances, according to the manufacturer.

As per Aurobindo Pharma, the approved product has a market size of USD 25.4 million for the 12 months ending October 2023, based on IQVIA data.

Aurobindo Pharma Limited is a multinational pharmaceutical manufacturing firm based in HITEC City in Hyderabad, India. The firm produces generic medications as well as active pharmaceutical ingredients. The company's therapeutic and product areas include antibiotics, anti-retrovirals, cardiovascular products, central nervous system products, gastroenterologicals, and anti-allergics. 

These products are sold in over 125 countries by the corporation. AstraZeneca and Pfizer are among its marketing partners.