The US Food and Drug Administration (FDA) has approved a new generic icatibant injection for the treatment of acute hereditary angioedema (HAE) swelling attacks, Aurobindo Pharma Limited announced.

The novel medication, manufactured by its wholly owned subsidiary Eugia Pharma Specialties Limited, is bioequivalent and therapeutically equivalent to the reference listed drug Firazyr®, an icatibant injection produced by a US company Takeda Pharmaceuticals.

The new drug is being manufactured as a prefilled syringe containing 30 mg/3 mL (10 mg/mL) of icatibant and is administered as a single dose. It is indicated for the treatment of HAE acute attacks in patients aged 18 years and older.

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“The product is being launched in September 2023. The approved product has an estimated market size of around US$137 million for the 12 months ending June 2023, according to IQVIA,” the Indian company officials noted.

Read more about HAE experimental therapies

Although generic therapies are typically less expensive than the chemically and therapeutically identical name-brand products, Aurobindo did not specify the price of the new icatibant generic.

After the 2011 FDA approval of Firazyr, a subcutaneous on-demand therapy for HAE attacks, companies including Cipla, Fresenius Kabi, Sandoz, and Glenmark Pharmaceuticals have come up with generic versions of Firazyr.

HAE attacks are marked by severe swelling driven by the overproduction of bradykinin, which causes blood vessels to relax and leak fluid into surrounding tissues. Icatibant stops the aberrant molecular signaling cascade by blocking the receptors for bradykinin.


Eugia Pharma receives USFDA approval for icatibant injection, 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe. News release. Aurobindo Pharma Limited; August 16, 2023.