Gland Pharma Ltd. announced on Tuesday that the US health government has approved its generic Edaravone injection for the treatment of amyotrophic lateral sclerosis.

According to the company’s regulatory filing, the US Food and Drug Administration (USFDA) has approved the company’s Edaravone injection of strengths 30 mg/100 ml and 60 mg/100 ml single-dose bags.

The injection is set to launch the product via its marketing partner during the ongoing fiscal year 2025.

Furthermore, it said that the product is therapeutically and bioequivalent to the reference-listed drug (RLD), Radicava injection (30 mg/100 ml and 60 mg/100 ml), manufactured by Mitsubishi Tanabe Pharma Corporation.

The Edaravone injection used to treat amyotrophic lateral sclerosis (ALS) results in the progressive death of the nerves that control muscle contraction and contraction, weakening the muscles.

Gland Pharma, utilising IQVIA data, reported about USD 19 million in sales in the US for the year ending in January 2024.