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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: panobinostat
Trade Name: Farydak
Date Designated: 08/20/2012
Orphan Designation: Treatment of multiple myeloma
Orphan Designation Status: Designated/Approved
Secura Bio, Inc.
11988 El Camino Real
Suite 650
San Diego, California 92130
United States

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

Marketing approved:

1 Generic Name: panobinostat
Trade Name: Farydak
Marketing Approval Date: 02/23/2015
Approved Labeled Indication: FARYDAK (panobinostat) in combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent
Exclusivity End Date: 02/23/2022 
Exclusivity Protected Indication* :  FARYDAK (panobinostat) in combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent

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