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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 (IV)
Trade Name: So-Aqueous
Date Designated: 07/25/2008
Orphan Designation: For ventricular tachycardia, ventricular fibrillation, or the maintenance of sinus rhythm in patients converted from atrial fibrillation or atrial flutter when oral administration is not possible.
Orphan Designation Status: Designated/Approved
AltaThera Pharmaceuticals LLC
311 South Wacker Drive
Suite 2275A
Chicago, Illinois 60606
United States

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

Marketing approved:

1 Generic Name: sotalol (IV)
Trade Name: So-Aqueous
Marketing Approval Date: 07/02/2009
Approved Labeled Indication: For use as a substitute for oral sotalol in patients who are unable to take sotalol orally [oral sotalol is indicated for maintenance of normal sinus rhythm in patients with history of highly symptomatic atrial fibrillation /flutter, and for treatment of documented life-threatening ventricular arrhythmias]
Exclusivity End Date: 07/02/2016 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.