Aurobindo Pharma arm secures USFDA okay for Icatibant Injection
Icatibant Injection is indicated for treatment of acute attacks of hereditary angioedema in adults 18 years of age and older.
Hyderabad: Aurobindo Pharma Limited has announced that its 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.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) FIRAZYR (Icatibant Injection) by Takeda Pharmaceuticals USA Inc.
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 166 th 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.
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