Eugia Pharma Specialities, a wholly-owned subsidiary of Aurobindo Pharma, on 16 August received approval from the USFDA (United States Food and Drug Administration to manufacture and market its generic Icatibant injection that is used in the treatment of hereditary angioedema.

The company has received a nod from USFDA for its Icatibant injection of strength 30 mg/3 mL (10 mg/mL), single-dose pre-filled syringe.

The drug is a bioequivalence and therapeutic equivalent of the reference listed drug FIRAZYR that Takeda Pharmaceuticals USA Inc produces.

The company said in a regulatory filing that the product is set to be launched in September 2023.

The Icatibant injection has an estimated market size of around $137 million for a year ending in June 2023, according to IQVIA data.

At 3:30 pm, the shares of Aurobindo Pharma Ltd closed at Rs 874.85 or 0.37% above its previous close on NSE.