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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
FDA Orphan Approval Status:  Approved for Orphan Indication
Approved Labeled Indication: For the management of postherpetic neuralgia 
Marketing Approval Date:  01/28/2011
Exclusivity End Date:  01/28/2018
Depomed, Inc.
1360 O'Brien Drive
Menlo Park, California 94025

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