USFDA approves Alembic Pharma Icatibant Injection for acute attacks of hereditary angioedema

Vadodara: Alembic Pharmaceuticals Limited today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Firazyr Injection, 30 mg/3 mL (10 mg/mL), of Takeda Pharmaceuticals U.S.A., Inc.

Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. 

Hereditary angioedema is a rare genetic disorder characterized by recurrent episodes of swelling (edema) in various parts of the body, including the face, limbs, abdomen, and throat. These episodes are caused by a deficiency or dysfunction of C1 esterase inhibitor, a protein involved in regulating the immune response and inflammation. HAE attacks can be triggered by stress, trauma, or certain medications, and they typically last for several days