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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: (RS)-baclofen, naltrexone and D-sorbitol
Date Designated: 03/17/2014
Orphan Designation: Treatment of Charcot-Marie-Tooth disease type 1A
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pharnext SA
11, rue des Peupliers
Issey-les-Moulineaux
France

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.
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