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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: L-baclofen
Date Designated: 01/30/1992
Orphan Designation: Treatment of intractable spasticity in children with cerebral palsy.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Osmotica Pharmaceutical Corp.
1205 Culbreth Drive
Suite 200
Wilmington, North Carolina 28405
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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