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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, CA 94025-1436

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