Search Orphan Drug Designations and Approvals
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Generic Name: | sodium oxybate | ||||||||||||||||
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Trade Name: | Lumryz | ||||||||||||||||
Date Designated: | 01/08/2018 | ||||||||||||||||
Orphan Designation: | Treatment of narcolepsy | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Flamel Ireland Limited dba Avadel Ireland 10 Earlsfort Terrace Dublin, Dublin Ireland 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: | sodium oxybate |
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Trade Name: | Lumryz | |
Marketing Approval Date: | 05/01/2023 | |
Approved Labeled Indication: | Treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy | |
Exclusivity End Date: | 05/01/2030 | |
Exclusivity Protected Indication* : | Treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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