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Viloxazine

Generic Name
Viloxazine
Brand Names
Qelbree
Drug Type
Small Molecule
Chemical Formula
C13H19NO3
CAS Number
46817-91-8
Unique Ingredient Identifier
5I5Y2789ZF

Overview

Viloxazine is a selective norepinephrine reuptake inhibitor. For decades, an immediate-release formulation of viloxazine has been used in Europe as an antidepressant. It was first approved in the UK in 1974; however, the immediate-release formulation was discontinued due to business reasons unrelated to drug safety and efficacy. In the US, viloxazine was assigned an orphan drug designation in 1984 under the brand name CATATROL: while this product was intended to treat cataplexy and narcolepsy, the drug was never approved for these therapeutic indications. In April 2021, an extended-release formulation of viloxazine under the brand name QELBREE was approved by the FDA for the treatment of attention deficit hyperactivity disorder (ADHD).

Background

Viloxazine is a selective norepinephrine reuptake inhibitor. For decades, an immediate-release formulation of viloxazine has been used in Europe as an antidepressant. It was first approved in the UK in 1974; however, the immediate-release formulation was discontinued due to business reasons unrelated to drug safety and efficacy. In the US, viloxazine was assigned an orphan drug designation in 1984 under the brand name CATATROL: while this product was intended to treat cataplexy and narcolepsy, the drug was never approved for these therapeutic indications. In April 2021, an extended-release formulation of viloxazine under the brand name QELBREE was approved by the FDA for the treatment of attention deficit hyperactivity disorder (ADHD).

Indication

Viloxazine is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.

Associated Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)

FDA Approved Products

QELBREE
Manufacturer:Supernus Pharmaceuticals, Inc
Route:ORAL
Strength:100 mg in 1 1
Approved: 2023/12/20
NDC:17772-131
QELBREE
Manufacturer:Supernus Pharmaceuticals, Inc
Route:ORAL
Strength:200 mg in 1 1
Approved: 2023/12/20
NDC:17772-133
QELBREE
Manufacturer:Supernus Pharmaceuticals, Inc
Route:ORAL
Strength:150 mg in 1 1
Approved: 2023/12/20
NDC:17772-132

Singapore Approved Products

No Singapore products found for this drug

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