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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: dehydrated alcohol
Trade Name: Ablysinol
Date Designated: 09/11/2013
Orphan Designation: Treatment of hypertrophic obstructive cardiomyopathy
Orphan Designation Status: Designated/Approved
Belcher Pharmaceuticals, LLC
6911 Bryan Dairy Road
Largo, Florida 33777
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: dehydrated alcohol
Trade Name: Ablysinol
Marketing Approval Date: 06/21/2018
Approved Labeled Indication: ABLYSINOL® 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.
Exclusivity End Date: 06/21/2025 
Exclusivity Protected Indication* :  ABLYSINOL® 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.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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