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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: gabapentin enacarbil
Trade Name: Horizant
Date Designated: 06/07/2011
Orphan Designation: Treatment of postherpetic neuralgia
Orphan Designation Status: Designated/Approved
Arbor Pharmaceuticals, LLC
6 Concourse Parkway
Suite 1800
Atlanta, Georgia 30328
United States

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

Marketing approved:

1 Generic Name: gabapentin enacarbil
Trade Name: Horizant
Marketing Approval Date: 06/06/2012
Approved Labeled Indication: Management of postherpetic neuralgia in adults.
Exclusivity End Date: 06/06/2019 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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