Aurobindo Pharma Secures USFDA Nod for Icatibant Injection
In a significant stride, Aurobindo Pharma, through its subsidiary Eugia Pharma Specialities, has clinched the final endorsement from the esteemed US Food & Drug Administration (USFDA) to produce and introduce its generic Icatibant injection. This particular injection stands as a pivotal component in the management of hereditary angioedema, a rare genetic disorder characterized by severe swelling beneath the skin.
The sanctioned Icatibant injection, boasting a potency of 30 mg/3 mL (equivalent to 10 mg/mL), has been developed as a single-dose pre-filled syringe. Aurobindo Pharma, in an official statement filed with regulatory authorities, expressed its delight over this regulatory accomplishment.
Distinguishing itself as a bioequivalent and therapeutically interchangeable alternative, this Icatibant injection mirrors the qualities of the reference listed drug FIRAZYR (Icatibant injection) produced by Takeda Pharmaceuticals USA Inc. The launch of Aurobindo Pharma’s innovative product is scheduled for September 2023.
Delving into the market dynamics, Aurobindo Pharma revealed that their newly endorsed Icatibant injection holds considerable potential. Drawing on data from IQVIA, the company noted that the estimated market scope for this product reached approximately USD 137 million in the 12-month period culminating in June 2023.
About Aurobindo Pharma:
Aurobindo Pharma Limited stands as an Indian multinational pharmaceutical manufacturing corporation with its headquarters situated in HITEC City, Hyderabad, India. This esteemed company specializes in producing generic pharmaceuticals and active pharmaceutical ingredients.
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