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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
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.

Marketing approved:

1 Generic Name: capsaicin
Trade Name: Qutenza
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* :  

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