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.
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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.
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