Aurobindo Pharma Arm Eugia Pharma Receives USFDA Approval For Icatibant Injection

Aurobindo Pharma Limited's wholly owned subsidiary company, Eugia Pharma Specialities Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Icatibant Injection, 30 mg/3 mL (10 mg/mL), Single-Dose Prefilled Syringe, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) FIRAZYR (Icatibant Injection) by Takeda Pharmaceuticals USA Inc the company announced on Wednesday through an exchange filing.

The product is being launched in September 2023. The approved product has an estimated market size of around US$ 137 million for the twelve months ending June 2023, according to IQVIA.

This is the 166th ANDA (including 9 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.

Icatibant Injection is indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Aurobindo Pharma shares

The shares of Aurobindo Pharma on Wednesday morning at 11:55 am IST were trading at Rs 874.55, up by 0.33 per cent.