Eugia Pharma’s Icatibant Injection, 30 mg/3 mL Single-Dose Prefilled Syringe, Secures USFDA Approval
Aurobindo Pharma
Aurobindo Pharma Limited is excited to announce a significant achievement by its wholly owned subsidiary, Eugia Pharma Specialities Limited. The subsidiary has received its final endorsement from the US Food & Drug Administration (USFDA) to produce and market Icatibant Injection, 30 mg/3 mL (10 mg/mL), Single-Dose Prefilled Syringe. This product has been determined to be both bioequivalent and therapeutically equivalent to the established reference listed drug (RLD), FIRAZYR® (Icatibant Injection) by Takeda Pharmaceuticals USA Inc. The official launch of this product is scheduled for September 2023.
This accomplishment is a notable milestone for Eugia Pharma Specialities Limited. The product has been projected to tap into an estimated market worth approximately US$ 137 million, based on data from IQVIA for the twelve months leading up to June 2023. It’s worth noting that this achievement marks the 166th ANDA approval (inclusive of 9 tentative approvals) from the facilities of Eugia Pharma Speciality Group (EPSG), which specializes in the manufacturing of both oral and sterile specialty products.
Icatibant Injection Unsees
Icatibant Injection holds a crucial medical purpose as it is designated for the treatment of acute attacks of hereditary angioedema (HAE) in adults aged 18 years and above.Top of Form
Hi there, just became alert to your blog through Google, and
found that it’s really informative. I’m going
to watch out for brussels. I’ll be grateful if
you continue this in future. Lots of people will be benefited
from your writing. Cheers!