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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Clonidine
Trade Name: Duraclon
Date Designated: 01/24/1989
Orphan Designation: For continous epidural administration as adjunctive therapy with intraspinal opiates for the treatment of pain in cancer patients tolerant to, or unresponsive to, intraspinal opiates.
Orphan Designation Status: Designated/Approved
Roxane Laboratories, Inc.
PO Box 16532
Columbus, Ohio 43216
United States

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

Marketing approved:

1 Generic Name: Clonidine
Trade Name: Duraclon
Marketing Approval Date: 10/02/1996
Approved Labeled Indication: In combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone.
Exclusivity End Date: 10/02/2003 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.