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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sterile processed derived multiple allogeneic proteins paracrine signaling
Date Designated: 05/20/2026
Orphan Designation: treatment of chronic graft versus host disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Regenerative Ocular Immunobiologics LLC
34170 US HWY 19 North
Palm Harbor, Florida 34684
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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