Search Orphan Drug Designations and Approvals
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Generic Name: | gabapentin enacarbil | ||||||||||||||||
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Trade Name: | Horizant | ||||||||||||||||
Date Designated: | 06/07/2011 | ||||||||||||||||
Orphan Designation: | Treatment of postherpetic neuralgia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | gabapentin enacarbil |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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