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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: inBreath airway transplant system
Date Designated: 09/04/2014
Orphan Designation: To restore the structure and/or function of the trachea subsequent to tracheal damage due to cancer, injury or infection
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Biostage, Inc.
84 October Hill Road
Suite 11
Holliston, Massachusetts 01746
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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