In a pivotal move bolstering its footprint in the global pharmaceutical landscape, Aurobindo Pharma Limited’s subsidiary, Eugia Pharma Specialities Limited, has achieved final authorization from the US Food & Drug Administration (FDA) to produce and commercialize their Icatibant Injection, 30 mg/3 mL. This development comes as a significant milestone as the injection stands as a bioequivalent and therapeutic counterpart to the acclaimed FIRAZYR (Icatibant Injection) by Takeda Pharmaceuticals USA Inc.

Anticipated to hit the markets in September 2023, the Icatibant Injection is poised to tap into an impressive market, with a projected size of approximately $137 million, as per IQVIA’s data for the year leading up to June 2023. This coveted FDA endorsement serves as a testament to Aurobindo Pharma’s relentless pursuit of excellence, with this marking their 166th ANDA approval, which encompasses both oral and sterile specialty products, from Eugia Pharma Speciality Group (EPSG) facilities.

The Icatibant Injection is specifically designed to cater to adults aged 18 and above, offering a robust solution for the acute attacks of hereditary angioedema (HAE). This latest approval not only exemplifies Eugia Pharma’s commitment to addressing critical health concerns but also strengthens Aurobindo Pharma’s position as a global pharmaceutical titan.

  Aurobindo Pharma, Eugia Pharma Specialities, FIRAZYR, hereditary angioedema, Icatibant Injection, India, Takeda Pharmaceuticals USA, US FDA