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.
Icatibant Injection Unsees
Icatibant Injection holds a crucial medical purpose as it is designated for the treatment of acute attacks of hereditary angioedema (HAE) in adults aged 18 years and above.Top of Form