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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
Date Designated: 09/26/1994
Orphan Designation: Treatment of spasticity associated with cerebral palsy.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Medtronic, Inc.
800 53rd Avenue N.E.
P.O. 1250
Minneapolis, Minnesota 55440
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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