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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: metformin
Date Designated: 12/14/2017
Orphan Designation: Treatment of progressive myoclonus epilepsy type 2 (Lafora disease)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Consorcio Centro de Investigación Biomédica en Red, M.P. (CIBER)
Monforte de Lemos
3-5 Pabellon 11
Madrid, Comunidad de Madrid

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.