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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: anti-T-lymphocyte immune globulin, rabbit
Date Designated: 09/12/2008
Orphan Designation: Prophylaxis of acute allograft rejection in adult recipients in solid organ transplantation
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Neovii Biotech GmbH
Am Haag 6 + 7
Graefelfing 82166
Germany

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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