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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: OZOBAX
Date Designated: 12/16/1991
Orphan Designation: Treatment of intractable spasticity due to multiple sclerosis or spinal cord injury.
Orphan Designation Status: Designated/Approved
Metacel Pharmaceuticals, LLC
244 E Washington Street
Athens, Georgia 30601
United States

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

Marketing approved:

1 Generic Name: baclofen
Trade Name: OZOBAX
Marketing Approval Date: 09/18/2019
Approved Labeled Indication: Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. OZOBAX may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Exclusivity End Date: N/A  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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