Gland Pharma Ltd. 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.

Plerixafor injection is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), MOZOBIL (plerixafor) injection of Genzyme Corporation, a subsidiary of Sanofi. Edaravone injection is bioequivalent and therapeutically equivalent to the Radicava injection of Mitsubishi Tanabe Pharma Corporation.

Gland Pharma said that Plerixafor is a hematopoietic stem cell mobiliser indicated in combination with filgrastim to mobilise hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation for patients diagnosed with non-Hodgkin's lymphoma or multiple myeloma.

Edaravone is used in the treatment of amyotrophic lateral sclerosis (ALS), a neuro-degenerative disorder characterised by the gradual degeneration of the nerves responsible for controlling muscle movement. This degeneration leads to muscle atrophy and weakness.

Gland Pharma said it anticipates the launch of Plerixafor and Edaravone injections through its marketing partner within the fiscal year 2025. According to IQVIA data, Plerixafor injection recorded US sales of approximately USD 152 million for the twelve months ending January 2024 while sales of Edaravone injection amounted to approximately USD 19 million for the twelve months ending January 2024.