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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: N-acetylprocainamide
Date Designated: 03/23/1990
Orphan Designation: To lower the defibrillation energy requirement sufficiently to allow automatic implantable cardioverter defibrillator therapy in those patients who could otherwise not use the device.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Medco Research, Inc.
8455 Beverly Blvd.
Suite 308
Los Angeles, California 90048
United States

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

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.