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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  capsaicin
Trade Name:  Qutenza
Date Designated:  05/22/2009
Orphan Designation:  Management of neuropathic pain in patients with postherpetic neuralgia
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  11/16/2009 
Approved Labeled Indication:  Management of neuropathic pain associated with postherpetic neuralgia
Exclusivity End Date:    11/16/2016 
Exclusivity Protected Indication* :  
Averitas Pharma, Inc.
360 Mount Kemble Avenue
Morristown, New Jersey 07960
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.