Alembic Pharmaceuticals announced that it has received final approval from US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Icatibant injection, single-dose prefilled syringe.
The approved drug is therapeutically equivalent to the reference listed drug product (RLD), Firazyr Injection 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.
Alembic has a cumulative total of 205 ANDA approvals (177 final approvals and 28 tentative approvals) from USFDA.
According to IQVIA, Icatibant injection had an estimated market size of $112 million for twelve months ending March 2024.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.
The company reported 16.78% increase in consolidated net profit to Rs 178.21 crore on 7.85% rise in revenue from operations to Rs 1,516.98 in Q4 FY24 over Q4 FY23.
The scrip rose 0.78% to end at Rs 890.10 on Friday, 14 June 2024. The stock market is closed today on occasion of Bakri-Id.
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First Published: Jun 17 2024 | 2:03 PM IST