Aurobindo Pharma Ltd. on Wednesday said that its wholly-owned subsidiary Eugia Pharma Specialities Ltd. has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Icatibant Injection, 30 mg/3 mL (10 mg/mL), used in the treatment of acute attacks of hereditary angioedema (HAE).

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The company will launch the product next month, Aurobindo Pharma said in a stock exchange filing.

Icatibant injection is used for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Angioedema is a condition which causes swelling of the deeper layers of the skin due to the build-up of fluid.

The injection, single-dose prefilled syringe, is bioequivalent and therapeutically equivalent to the reference listed drug FIRAZYR by Takeda Pharmaceuticals USA Inc.

According to IQVIA data, Icatibant injection has an estimated market size of $137 million for the 12 months ended June 2023.

Aurobindo Pharma stated the recent approval is the 166th ANDA, including nine tentative approvals, out of Eugia Pharma Speciality Group (EPSG) facilities.

Eugia Pharma manufactures both oral and sterile specialty products.

Aurobindo Pharma last week announced a 10 percent rise in consolidated net profit to Rs 571 crore in the June quarter against Rs 520.5 crore last year due to robust sales across geographies.

Its revenue increased to Rs 6,850.5 crore in the June quarter from Rs 6,236 crore a year ago.

The Hyderabad-based firm in a statement had stated that the company was confident of strengthening its position as the product pipeline continued to advance, and execution of growth drivers progressed as planned.

Shares of Aurobindo Pharma are trading 1.3 percent higher at Rs 882.60.