• 25 Jun 2025
• Admin
• News Article

Breckenridge Pharmaceutical announces final FDA approval for Dehydrated Alcohol Injection, USP (generic for Ablysinol®)

Overview

Breckenridge Pharmaceutical, Inc., the U.S. subsidiary of Towa International that markets, distributes, and sells generic medicines in the United States, announced today that the Food and Drug Administration (FDA) has granted approval of its Dehydrated Alcohol Injection, USP, 5 mL of ≥ 99% by volume ethyl alcohol Single-Dose Vials, a generic version of Ablysinol® by Belcher Pharmaceuticals, LLC, developed in partnership with Andersen Pharma Global.

The Dehydrated alcohol injection

• Dehydrated alcohol injection is a sterile, preservative free solution of ≥ 99% by volume ethyl alcohol and no excipients and meets the quality and purity standards set by the United States Pharmacopeia (USP). 

• It is indicated for the induction of controlled cardiac septal infarction to improve exercise capacity in adult patients with symptomatic hypertrophic obstructive cardiomyopathy (HOCM) who are not suitable candidates for surgical myectomy. 

• Dehydrated Alcohol Injection, USP, will be available primarily in hospitals, clinics, and home health care facilities.

Statement from the Breckenridge Pharmaceutical

Brian Guy, President and Chief Commercial Officer of Breckenridge Pharmaceutical, states: ""The approval and launch of our Dehydrated Alcohol Injection, USP, is a significant achievement, positioning Breckenridge as one of the first companies in the U.S. market to offer a generic alternative to Ablysinol®. This milestone reflects our continued dedication to providing affordable treatment options that meet real patient needs and reinforces our commitment to serving the institutional channel.""

Breckenridge Launch Marks Strategic Expansion in U.S. Healthcare Market

• The launch represents a key milestone in Breckenridge's strategic plan, supporting its short- and mid-term goals.

• It reflects the company's focus on expanding its footprint in the institutional healthcare channel.

• The initiative enhances Breckenridge’s diversified portfolio, with new additions in:

Oncology
Autoimmune diseases
Rare diseases
Supportive care

• The company reaffirms its commitment to improving patient access and broadening therapeutic options in the U.S. market.

• The approval also supports Towa International’s global mission to increase access to high-quality, affordable medicines worldwide.

• Breckenridge remains committed to working closely with healthcare professionals and institutional partners to ensure the availability of Dehydrated Alcohol Injection, USP, and to support the appropriate use of this treatment option.

*Please visit www.breckenridgepharma.com for the full prescribing information for warnings and precautions, and adverse reactions.

*All brand names and trademarks are the property of their respective owners.

About Breckenridge Pharmaceutical, Inc.:

• Breckenridge Pharmaceutical, Inc., (New Jersey), the U.S. subsidiary of Towa International (Barcelona, Spain), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. 

• With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we strive to impact the health of the patients we and our customers serve.

www.breckenridgepharma.com

For further information, please contact:
Towa International / Breckenridge Pharmaceutical, Inc. 
External Comm and IR team
Email: media@towapharmaceutical.com 

About Andersen Pharma Global:

• The development partner for this product, Andersen Pharma Global, is a U.S.-focused company specializing in the identification, development, manufacturing, and supply of pharmaceutical products. 

• With a strong track record of delivering affordable medicines and ensuring consistent supply, Andersen Pharma continues to play a vital role in improving patient access to essential therapies.