Icatibant Injection 30 mg/3 mL Single-Dose Prefilled Syringe, Secures USFDA Approval

Aurobindo Pharma

Aurobindo Pharma Limited is excited to announce a significant achievement by its wholly owned subsidiary, Eugia Pharma Specialities Limited. The subsidiary has received its final endorsement from the US Food & Drug Administration (USFDA) to produce and market Icatibant Injection, 30 mg/3 mL (10 mg/mL), Single-Dose Prefilled Syringe. This product has been determined to be both bioequivalent and therapeutically equivalent to the established reference listed drug (RLD), FIRAZYR® (Icatibant Injection) by Takeda Pharmaceuticals USA Inc. The official launch of this product is scheduled for September 2023.

This accomplishment is a notable milestone for Eugia Pharma Specialities Limited. The product has been projected to tap into an estimated market worth approximately US$ 137 million, based on data from IQVIA for the twelve months leading up to June 2023. It’s worth noting that this achievement marks the 166th ANDA approval (inclusive of 9 tentative approvals) from the facilities of Eugia Pharma Speciality Group (EPSG), which specializes in the manufacturing of both oral and sterile specialty products.

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