Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Icatibant Injection used for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
The USDFA approval is for Icatibant Injection of strengths of 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, stated the Vadodara-based company on Monday. This is the first peptide product approval from the USFDA received by the Company.
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 has an estimated market size of USD 112 million for twelve months ending March 2024 according to IQVIA.
Alembic has a cumulative total of 205 ANDA approvals (177 final approvals and 28 tentative approvals) from USFDA, the company stated.