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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: topiramate injection
Date Designated: 07/24/2013
Orphan Designation: Treatment of partial onset or primary generalized tonic-clonic seizures for hospitalized epilepsy patients or epilepsy patients being treated in an emergency care setting who are unable to take oral topiramate
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
CURx Pharmaceuticals, Inc.
3210 Merryfield Row
San Diego, California 92121
United States

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

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.