The US Food & Drug Administration (USFDA) has granted Alembic Pharmaceuticals Limited final clearance for its Abbreviated New Drug Application (ANDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe. 

The authorised ANDA is therapeutically similar to Takeda Pharmaceuticals U.S.A., Inc.'s reference listed drug product (RLD), Firazyr Injection, 30 mg/3 mL (10 mg/mL), according to the company's statement.

For people eighteen years of age and above, it is recommended to treat acute episodes of hereditary angioedema (HAE) with isatinibant injection. This is the first time the company has gained clearance for a peptide product from the USFDA.

IQVIA estimates that the market for Icatibant Injection will be worth US$ 112 million by the end of March 2024. Alembic has received 205 ANDA approvals in total from the USFDA (177 final approvals and 28 tentative clearances).