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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Sotalol HCl
Trade Name: Betapace
Date Designated: 09/23/1988
Orphan Designation: 1. Treatment of life-threatening ventricular tachyarrhythmias 2. Prevention of life treatening ventricular tachyarrhythmias
Orphan Designation Status: Designated/Approved
Berlex Laboratories, Inc.
300 Fairfield Road
Wayne, New Jersey 07470
United States

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

Marketing approved:

1 Generic Name: Sotalol HCl
Trade Name: Betapace
Marketing Approval Date: 10/30/1992
Approved Labeled Indication: Treatment of life-threatening ventricular tachyarrhythmias
Exclusivity End Date: 10/30/1999 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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