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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: vancomycin hydrochloride (inhalational)
Date Designated: 09/20/2012
Orphan Designation: Treatment of persistent methicillin-resistant S. aureus lung infection in patients with cystic fibrosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Savara Inc.
1717 Langhorne Newtown Road, Suite 300
Langhorne, Pennsylvania 19047
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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