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Search Orphan Drug Designations and Approvals - FDA

- Generic Name: thymosin beta 4 Date Designated: 12/31/2013 Orphan Designation: Treatment of patients with neurotrophic keratopathy Orphan Designation Status: Designated FDA Orphan Approval Status: Not FDA Approved for Orphan Indication Sponsor: ReGenTree, LLC 116 Village Blvd Suite 200 Princeton, New Jersey 08540 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 *Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013. -

thymosin beta-4 fda tga wada usada warnings
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Study findings do not automatically establish clinical benefit, safety, dosing, or suitability for an individual.

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Generic Name: thymosin beta 4 Date Designated: 12/31/2013 Orphan Designation: Treatment of patients with neurotrophic keratopathy Orphan Designation Status: Designated FDA Orphan Approval Status: Not FDA Approved for Orphan Indication Sponsor: ReGenTree, LLC 116 Village Blvd Suite 200 Princeton, New Jersey 08540 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 *Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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