Search Orphan Drug Designations and Approvals
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Generic Name: | Clonidine | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
Roxane Laboratories, Inc. PO Box 16532 Columbus, Ohio 43216 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | Clonidine |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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