Alembic Pharmaceuticals Gains USFDA Approval for Icatibant Injection


Mumbai, June 18: 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. This is the first peptide product approval from the USFDA received by the Company.

Icatibant Injection has an estimated market size of US$ 112 million for twelve months ending Mar 2024 according to IQVIA.

Alembic has a cumulative total of 205 ANDA approvals (177 final approvals and 28 tentative approvals) from USFDA.