Alembic Pharmaceuticals announces USFDA Final Approval for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe

Alembic Pharmaceuticals Limited (Alembic) 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. Refer label for a detailed indication.

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.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 890.10 as compared to the previous close of Rs. 883.25. The total number of shares traded during the day was 12093 in over 1181 trades.

The stock hit an intraday high of Rs. 910.00 and intraday low of 885.00. The net turnover during the day was Rs. 10839202.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 USFDA FinalApproval IcatibantInjection