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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: monepantel
Date Designated: 05/16/2024
Orphan Designation: treatment of amyotrophic lateral sclerosis (ALS) / motor neuron disease (MND)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Neurizon Therapeutics LLC
156 W 56th St, FL 3
New York, New York 10019
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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