USFDA approves Alembic Pharma Icatibant Injection for acute attacks of hereditary angioedema
Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema in adults 18 years of age and older.;
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
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