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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Type 1 native bovine skin collagen
Date Designated: 02/01/2008
Orphan Designation: Treatment of diffuse systemic sclerosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
arGentis Pharmaceuticals, LLC
20 South Dudley Street
Memphis, Tennessee 38139
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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