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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: mexiletine
Date Designated: 09/02/2010
Orphan Designation: Treatment of nondystrophic myotonia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
University of Rochester Medical Center
1351 Mt. Hope Ave.
Suite 203
Rochester, New York 14620
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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