USFDA gives approval for Icatibant injection

The approval comes as a testament to Aurobindo Pharma's commitment to providing effective and affordable healthcare solutions to the masses.

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 24, 2023 by The Health Master

USFDA Approval

In a significant development, Aurobindo Pharma’s subsidiary, Eugia Pharma Specialities, has achieved a major milestone by obtaining the final nod from the esteemed US Food & Drug Administration (USFDA) for the production and distribution of a generic Icatibant injection.

Icatibant injection is widely employed in the treatment of a genetic disorder known as hereditary angioedema.

The approval comes as a testament to Aurobindo Pharma’s commitment to providing effective and affordable healthcare solutions to the masses.

Let’s delve into the details of this groundbreaking achievement.

USFDA Greenlight for Eugia Pharma Specialities’ Icatibant Injection

Eugia Pharma Specialities, a wholly-owned subsidiary of Aurobindo Pharma, has secured the coveted seal of approval from the USFDA for its Icatibant injection.

This injection, available in the strength of 30 mg/3 mL (10 mg/mL) as a single-dose pre-filled syringe, is a vital therapeutic option in the management of hereditary angioedema—a condition characterized by episodes of severe swelling beneath the skin, in the airways, and other body organs.

Hereditary angioedema (HAE) is an autosomal dominant disease caused by either a lack of C1-inhibitor protein or dysfunctional C1-inhibitor protein. HAE manifests with symptoms related to angioedema of the upper airway, skin, and/ or gastrointestinal tract.

Equivalent to FIRAZYR by Takeda Pharmaceuticals USA Inc

The approved Icatibant injection by Eugia Pharma Specialities stands as a bioequivalent and therapeutically equivalent alternative to the reference listed drug FIRAZYR, initially developed by Takeda Pharmaceuticals USA Inc.

This achievement underscores Aurobindo Pharma’s dedication to delivering high-quality medications that meet the same therapeutic standards as established brands, while also offering more accessible options to patients.

Upcoming Launch and Market Impact

Anticipating an official product launch in September 2023, Aurobindo Pharma is on track to introduce its Icatibant injection to the market.

This product launch is poised to have a significant positive impact on patients suffering from hereditary angioedema, providing them with a trusted and cost-effective treatment alternative.

Market Size and Potential

Based on data provided by IQVIA, Aurobindo Pharma has projected that the newly approved Icatibant injection holds a substantial estimated market size, amounting to approximately USD 137 million.

This estimation covers the period of the preceding 12 months, ending in June 2023.

Such promising market potential underscores the demand for effective hereditary angioedema treatments and highlights the strategic position of Aurobindo Pharma in addressing this need.

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

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