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Aurobindo Pharma Gets USFDA Approval for Icatibant Injection

 A significant achievement for Aurobindo Pharma emerges as its wholly-owned subsidiary, Eugia Pharma Specialities, gains the final green light from the US health authority for the production and distribution of a generic Icatibant injection. This injection is integral in addressing hereditary angioedema.

The endorsement, bestowed by the US Food & Drug Administration (USFDA), pertains to the 30 mg/3 mL (10 mg/mL) strength of Icatibant injection, presented as a single-dose pre-filled syringe. Aurobindo Pharma disclosed this development through an official filing.

Distinguished as both bioequivalent and therapeutically tantamount to Takeda Pharmaceuticals USA Inc’s reference listed drug FIRAZYR (Icatibant injection), this milestone holds considerable significance.

The company announced the scheduled launch of this product in September 2023. Drawing attention to its market potential, Aurobindo Pharma indicated that the approved offering corresponds to a market size valued at approximately USD 137 million, as per IQVIA data encompassing the 12 months concluding in June 2023.

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