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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: baclofen
Trade Name: Lioresal Intrathecal
Date Designated: 11/10/1987
Orphan Designation: Treatment of intractable spasticity caused by spinal cord injury, multiple sclerosis, and other spinal diseases (including spinal ischemia, spinal tumor, transverse myelitis, cervical spondylosis, and degenerative myelopathy).
Orphan Designation Status: Designated/Approved
Medtronic, Inc.
800 53rd Avenue N.E.
Minneapolis, Minnesota 55432
United States

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

Marketing approved:

1 Generic Name: baclofen
Trade Name: Lioresal Intrathecal
Marketing Approval Date: 06/25/1992
Approved Labeled Indication: Management of severe spasticity of spinal cord origin in patients who are unresponsive to oral baclofen therapy or experience intolerable CNS side effects at effective doses.
Exclusivity End Date: 06/25/1999 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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