USFDA approval granted for Edaravone Injection

This USFDA approval positions Gland Pharma to tap into this growing market and potentially make a significant impact on the lives of ALS patients.

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USFDA Drug product Approval
USFDA Approval

Last Updated on May 28, 2024 by The Health Master

USFDA approval

Positive News for ALS Patients and the Pharmaceutical Industry

Gland Pharma, a leading pharmaceutical manufacturer, has secured a significant USFDA approval from the US Food and Drug Administration (USFDA) for its generic Edaravone injection.

This injectable medication is a promising treatment for Amyotrophic Lateral Sclerosis (ALS), a debilitating neurodegenerative disease.

Edaravone Injection

What is ALS?

Amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease, is a progressive neurological disorder that attacks the nerve cells responsible for muscle movement.

As the disease progresses, muscles weaken and atrophy, leading to difficulty with speaking, swallowing, breathing, and eventually, paralysis.

How Does Edaravone Injection Work?

The exact mechanism of action for Edaravone is still under investigation, but it’s believed to work by reducing oxidative stress, a cellular process that damages nerves.

This may help to slow the progression of ALS and improve symptoms.

Gland Pharma’s Edaravone Injection:

  • Available in two strengths: 30 mg/100 mL and 60 mg/100 mL, offered in single-dose bags for convenient administration.
  • Bioequivalent and therapeutically equivalent to the reference drug Radicava by Mitsubishi Tanabe Pharma Corporation, ensuring efficacy and safety.

A Lucrative Market Opportunity

The ALS treatment market is projected to experience significant growth in the coming years.

According to IQVIA data, Edaravone generated an estimated USD 19 million in sales within the US alone for the twelve months ending January 2024.

This USFDA approval positions Gland Pharma to tap into this growing market and potentially make a significant impact on the lives of ALS patients.

Looking Ahead

Gland Pharma anticipates launching the Edaravone injection through a marketing partner within the current fiscal year (FY25).

This USFDA approval signifies a crucial step forward in providing patients with access to this potentially life-changing medication.

With its generic status, Edaravone has the potential to increase affordability and treatment options for ALS patients, offering a beacon of hope in the fight against this devastating disease.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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