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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: liposomal ciprofloxacin plus ciprofloxacin
Date Designated: 06/01/2012
Orphan Designation: For the management of cystic fibrosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Savara Inc.
6836 Bee Cave Road, Building 3, Suite 200
Austin, Texas 78746
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.