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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
Trade Name:  Gralise
Date Designated:  11/08/2010
Orphan Designation:  Management of postherpetic neuralgia
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  01/28/2011 
Approved Labeled Indication:  For the management of postherpetic neuralgia
Exclusivity End Date:    01/28/2018 
Exclusivity Protected Indication* :  
Golf Acquiror LLC
44 Whippany Road
Suite 300
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.