Gland Pharma receives USFDA approval for generic Edaravone injection

Gland Pharma gains USFDA approval for generic Edaravone injection, treating Amyotrophic Lateral Sclerosis (ALS). The product, bioequivalent to Radicava, is expected for launch in FY25 through a marketing partnership. ALS involves progressive nerve damage affecting muscle movement. Edaravone injection had US sales of around USD 19 million for the year ending January 2024.

Gland Pharma Ltd on Tuesday said it has received approval from the US health regulator for its generic Edaravone injection to treat amyotrophic lateral sclerosis.

The approval by the US Food and Drug Administration (USFDA) is for Edaravone injection of strengths 30 mg/100 ml and 60 mg/100 ml single-dose bags, Gland Pharma said in a regulatory filing.

The company expects to launch the product through its marketing partner within FY25, it added.

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Radicava injection, 30 mg/100 ml and 60 mg/100 ml of Mitsubishi Tanabe Pharma Corporation, it added.

Edaravone injection is used to treat amyotrophic lateral sclerosis (ALS), a condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken.

It had sales of approximately USD 19 million in the US for the 12 months ended January 2024, Gland Pharma said citing IQVIA data.

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