Aurobindo Pharma Gets USFDA Nod for Generic Icatibant Injection, Launching Soon

17 Aug 2023 , 11:54 AM

Aurobindo Pharma’s subsidiary, Eugia Pharma Specialities, has received final approval from the USFDA for generic Icatibant injection used in treating hereditary angioedema. The approved injection is of strength 30 mg/3 mL (10 mg/mL) and comes in a single-dose pre-filled syringe.

The product is considered bioequivalent and therapeutically equivalent to Takeda Pharmaceuticals’ reference listed drug FIRAZYR. Aurobindo Pharma announced the product’s launch in September 2023. The approved product’s market size is estimated to be approximately USD 137 million based on IQVIA data for the 12 months ending June 2023.

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