Breckenridge Pharmaceutical Inc, the US subsidiary of Spain-based Towa International that markets, distributes and sells generic medicines in the United States, announced on Tuesday that the Food and Drug Administration (FDA) has approved its Dehydrated Alcohol Injection, USP, 5 mL of greater than 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 product is a sterile, preservative free solution of greater than 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.