USFDA approval granted for Icatibant injection prefilled syringe

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USFDA Drug product Approval
USFDA Approval

Last Updated on June 28, 2024 by The Health Master

USFDA approval

Alembic Pharmaceuticals, a leading vertically integrated research and development pharmaceutical company, has achieved a significant milestone by securing final USFDA approval from the US Food and Drug Administration (USFDA) for its Icatibant injection.

This injectable medication, available in a convenient single-dose prefilled syringe (30 mg/3 mL or 10 mg/mL), is specifically indicated for treating acute attacks of hereditary angioedema (HAE) in adults aged 18 and above.

First Peptide Product Greenlight

This USFDA approval marks a historic moment for Alembic, representing their first-ever USFDA nod for a peptide product.

Peptides are a unique class of drugs composed of short chains of amino acids, often offering targeted and effective treatment options for various conditions.

This successful application demonstrates Alembic’s expanding capabilities in the development and manufacturing of complex pharmaceutical products.

Addressing a High-Value Market Need

Hereditary angioedema (HAE) is a rare genetic disorder characterized by recurrent episodes of severe swelling that can affect the face, abdomen, extremities, and even the airway.

Icatibant injection offers a rapid-acting solution to manage these acute attacks, potentially improving patient outcomes and quality of life.

Market Potential

According to IQVIA, the market size for Icatibant injection is estimated at a substantial USD 112 million for the twelve months ending March 2024.

This USFDA approval positions Alembic to tap into this lucrative market segment and further strengthen their position in the US pharmaceutical landscape.

Alembic’s Proven Expertise in ANDA Approvals

This recent Icatibant injection approval adds to Alembic’s impressive track record with the USFDA.

The company boasts a cumulative total of 205 ANDA approvals, including 177 final approvals and 28 tentative approvals.

This signifies their commitment to developing high-quality generic medications that meet the needs of patients and healthcare professionals in the United States.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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