Aurobindo Pharma gets USFDA nod to make, market generic Icatibant injection

The approval granted by USFDA is for Icatibant injection of strength 30 mg/3 mL (10 mg/mL), single-dose pre-filled syringe, Aurobindo Pharma said in a regulatory filing

Aurobindo Pharma on Wednesday said its wholly-owned arm Eugia Pharma Specialities has received final approval from the US health regulator to manufacture and market generic Icatibant injection used in treatment of hereditary angioedema.

The approval granted by the US Food & Drug Administration (USFDA) is for Icatibant injection of strength 30 mg/3 mL (10 mg/mL), single-dose pre-filled syringe, Aurobindo Pharma said in a regulatory filing.

It is the bioequivalent and therapeutically equivalent of reference listed drug FIRAZYR (Icatibant injection) by Takeda Pharmaceuticals USA Inc, it added.

"The product is being launched in September 2023," Aurobindo Pharma said.

The approved product has an estimated market size of around USD 137 million for the 12 months ended June 2023, the company said citing IQVIA data.