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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (-)-(3aR,4S,7aR)-4-Hydroxy-4-m-tolylethynyl-octahydro-indole-1-carboxylic acid methyl ester
Date Designated: 10/12/2011
Orphan Designation: Treatment of Fragile X syndrome
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Stalicla SA
Campus Biotech Innovation Park
Avenue de Secheron 15
Geneve 1202
Switzerland

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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