Drug Profile
Sodium oxybate - Avadel Pharmaceuticals
Alternative Names: FT-218; LUMRYZ; Micropump® sodium oxybate; ON-SXBLatest Information Update: 06 Mar 2024
Price :
$50
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At a glance
- Originator Flamel Technologies
- Developer Avadel Pharmaceuticals
- Class Butyric acids; Hydroxybutyrates; Sleep disorder therapies; Small molecules
- Mechanism of Action GABA B receptor agonists
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Marketed Narcolepsy
Most Recent Events
- 06 Mar 2024 Planned Prescription Drug User Fee Act (PDUFA) date for Narcolepsy (In children) in USA (PO) is 2024-09-07
- 04 Mar 2024 Avadel Pharmaceuticals issues statement on jury's ruling in patent litigation against Jazz Pharmaceuticals regarding sodium oxybate
- 04 Mar 2024 Avadel Pharmaceuticals anticipates supplemental new drug application (sNDA) approval for Narcolepsy (In Children) in the USA on September 07, 2024