Search Orphan Drug Designations and Approvals
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| Generic Name: | panobinostat | ||||||||||||||||
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| Trade Name: | Farydak | ||||||||||||||||
| Date Designated: | 08/20/2012 | ||||||||||||||||
| Orphan Designation: | Treatment of multiple myeloma | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
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. |
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Marketing approved: |
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| 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 | |
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