Search Orphan Drug Designations and Approvals
-
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 | ||||||||||||||||
Sponsor: |
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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-