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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
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.
Belcher Pharmaceuticals, LLC
6911 Bryan Dairy Road
Largo, Florida 33777
USA

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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