Dehydrated Alcohol — Avenacy, LLC drug label update
Avenacy, LLC has updated the drug label for Dehydrated Alcohol injection, which is indicated for inducing controlled cardiac septal infarction in adults with symptomatic hypertrophic obstructive cardiomyopathy (HOCM) who are not candidates for surgical myectomy.
This update affects Avenacy, LLC, as well as clinical and regulatory professionals managing treatments for hypertrophic obstructive cardiomyopathy and surgical myectomy alternatives.
The labeling update reinforces the precise clinical application of dehydrated alcohol as an ablative agent for cardiac septal infarction. This suggests a continued regulatory focus on ensuring that specialized, high-risk procedures like cardiac ablation are supported by specific indications for patients who lack surgical options.
Regulatory teams should ensure that product labeling for Dehydrated Alcohol injection clearly reflects the specific patient population (HOCM patients ineligible for surgery) and the mechanism of action as a cardiac ablative agent to maintain compliance with the updated FDA-approved indications.
Dehydrated Alcohol (Avenacy, LLC). 1 INDICATIONS AND USAGE Dehydrated alcohol injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. Dehydrated alcohol injection is an ablative agent indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. ( 1 )
Open in openFDA / FDA.gov