Gland Pharma gets USFDA approval for generic Edaravone injection

7 May 2024 , 03:01 PM

Gland Pharma Ltd announced on Tuesday that it has obtained approval from the US Food and Drug Administration (USFDA) for its generic Edaravone injection used in treating amyotrophic lateral sclerosis (ALS).

The approved strengths of Edaravone injection are 30 mg/100 ml and 60 mg/100 ml single-dose bags. The company plans to launch the product in the fiscal year 2025 through its marketing partner.

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

Edaravone injection is prescribed for the treatment of ALS, a condition characterized by the gradual degeneration of nerves controlling muscle movement, leading to muscle atrophy and weakness.

Gland Pharma cited IQVIA data stating that Edaravone injection had sales of approximately USD 19 million in the US for the 12 months ending January 2024.

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