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Viloxazine
Qelbree (viloxazine) is a small molecule pharmaceutical. Viloxazine was first approved as Qelbree on 2021-04-02. It is used to treat depression in the USA.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
behavior and behavior mechanismsD001520
Trade Name
FDA
EMA
Qelbree
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Viloxazine hydrochloride
Tradename
Company
Number
Date
Products
QELBREESupernus PharmaceuticalsN-211964 RX2021-04-02
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
qelbreeNew Drug Application2021-04-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
depression—D003863F33.9
Agency Specific
FDA
EMA
Expiration
Code
VILOXAZINE HYDROCHLORIDE, QELBREE, SUPERNUS PHARMS
2026-04-02NCE
2025-04-29NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Viloxazine Hydrochloride, Qelbree, Supernus Pharms
93582042033-02-07DP
96038532033-02-07U-727
96623382033-02-07DP
113247532029-09-04U-727
114581432029-09-04U-727
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06A: Antidepressants
— N06AX: Other antidepressants in atc
— N06AX09: Viloxazine
HCPCS
No data
Clinical
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVILOXAZINE
INNviloxazine
Description
2-[(2-ethoxyphenoxy)methyl]morpholine is an aromatic ether.
Classification
Small molecule
Drug class-
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCOc1ccccc1OCC1CNCCO1
Identifiers
PDB—
CAS-ID46817-91-8
RxCUI11196
ChEMBL IDCHEMBL306700
ChEBI ID—
PubChem CID5666
DrugBankDB09185
UNII ID5I5Y2789ZF (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Qelbree - Supernus Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 321 documents
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Safety
Black-box Warning
Black-box warning for: Qelbree
Adverse Events
Top Adverse Reactions
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33,875 adverse events reported
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