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~ This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals~
17th June 2024, Bengaluru: 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.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic’s brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients.
Information about Alembic can be found at https://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLLTD) (BSE: 533573)
