Gland Pharma receives USFDA approval for generic Edaravone injection for ALS treatment.

Gland Pharma receives USFDA approval for generic Edaravone injection to treat ALS. The 30 mg/100 ml and 60 mg/100 ml injection strengths are bioequivalent and therapeutically equivalent to Radicava injection by Mitsubishi Tanabe Pharma. Gland Pharma plans to launch the product through a marketing partner within FY25, with US sales of approximately $19M in the 12 months ending January 2024.