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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: 05/29/2014
Orphan Designation: Treatment of pediatric polycystic ovary syndrome
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 03/19/2021
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
EffRx Pharmaceuticals SA
Wolleraustrass 41 B
8807 Freienbach (SZ)

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.