New Delhi, Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for generic icatibant injection indicated to treat acute attacks of hereditary angioedema in adults.

Approval by the US Food and Drug Administration (USFDA) of an Abbreviated New Drug Application (ANDA) for Icatibant Injection, single-dose prefilled syringe with a capacity of 30 mg/3 mL (10 mg/mL), Alembic Pharmaceuticals said in a regulatory filing. Have taken. Sign in.

This is the first peptide product approval the company has received from the USFDA, Alembic Pharma said.

The approved ANDA is therapeutically equivalent to Takeda Pharmaceuticals USA, Inc.'s reference listed drug product (RLD), Firazire Injection, 30 mg/3 mL (10 mg/mL).

Icatibant injection is indicated to treat acute attacks of hereditary angioedema (HAE) in adults aged 18 years and older.

Hereditary angioedema is a disorder characterized by repeated episodes of severe swelling (angioedema) in different parts of the body.

The estimated market size of injectables for the 12 months ending March 2024 is US$112 million, the company said, citing IQVIA data.