Eugia Pharma Specialities, a wholly owned subsidiary of Aurobindo Pharma, received final approval on Wednesday from the US Food and Drug Administration, or the USFDA, to manufacture and market generic Icatibant injection used in the treatment of hereditary angioedema.

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"The Company in connection with USFDA approval received by Eugia Pharma Specialities Limited, a wholly owned subsidiary of the company, for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe," the filing read.

The approval granted by the USFDA is for an Icatibant injection of strength 30 mg/3 mL (10 mg/mL), single-dose pre-filled syringe. It is the bioequivalent and therapeutically equivalent of reference-listed drug FIRAZYR (Icatibant injection) by Takeda Pharmaceuticals USA Inc.

"The product is being launched in September 2023," Aurobindo Pharma said.

The approved product has an estimated market size of around USD 137 million for the 12 months ended June 2023, the company said, citing IQVIA data.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercialises a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients globally in over 150 countries.

(With PTI inputs)

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