MedPath

Duloxetine

Generic Name
Duloxetine
Brand Names
Cymbalta, Drizalma, Irenka, Yentreve, Duloxetine Zentiva, Duloxetine Mylan, Duloxetine Lilly
Drug Type
Small Molecule
Chemical Formula
C18H19NOS
CAS Number
116539-59-4
Unique Ingredient Identifier
O5TNM5N07U

Overview

Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor. It was originally discovered in 1993 and developed by Eli Lilly and Company as LY248686. Duloxetine first received approval from the FDA in August, 2004 as Cymbalta for the treatment of Major Depressive Disorder. It has since received approval for a variety of indications including the treatment of neuropathic pain, Generalized Anxiety disorder, osteoarthritis, and stress incontinence. Duloxetine continues to be investigated for the treatment of pain in cancer, surgery, and more.

Background

Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor. It was originally discovered in 1993 and developed by Eli Lilly and Company as LY248686. Duloxetine first received approval from the FDA in August, 2004 as Cymbalta for the treatment of Major Depressive Disorder. It has since received approval for a variety of indications including the treatment of neuropathic pain, Generalized Anxiety disorder, osteoarthritis, and stress incontinence. Duloxetine continues to be investigated for the treatment of pain in cancer, surgery, and more.

Indication

Indicated for: 1) Management of Major Depressive Disorder. 2) Management of Generalized Anxiety Disorder. 3) Management of diabetic peripheral neuropathy. 4) Management of fibromyalgia. 5) Management of chronic musculoskeletal pain. 6) Management of osteoarthritis of the knee in adults. 7) Management of chronic lower back pain in adults. 8) Management of stress urinary incontinence in adult women. Off-label uses include: 1) Management of chemotherapy-induced peripheral neuropathy. 2) Management of stress urinary incontinence in adult men after prostatectomy until recovery is complete.

Associated Conditions

  • Chronic Lower Back Pain (CLBP)
  • Chronic Musculoskeletal Pain
  • Diabetic Peripheral Neuropathic Pain (DPN)
  • Fibromyalgia
  • Generalized Anxiety Disorder
  • Major Depressive Disorder (MDD)
  • Osteoarthritis of the Knee
  • Stress Urinary Incontinence (SUI)

FDA Approved Products

DULOXETINE HYDROCHLORIDE
Manufacturer:DIRECT RX
Route:ORAL
Strength:60 mg in 1 1
Approved: 2023/03/30
NDC:61919-042
Duloxetine
Manufacturer:Quality Care Products, LLC
Route:ORAL
Strength:20 mg in 1 1
Approved: 2019/03/01
NDC:55700-727
Duloxetine
Manufacturer:Lupin Pharmaceuticals, Inc.
Route:ORAL
Strength:20 mg in 1 1
Approved: 2023/12/12
NDC:68180-294
Duloxetine Delayed-Release
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:60 mg in 1 1
Approved: 2021/10/31
NDC:71335-0509
Duloxetine
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:60 mg in 1 1
Approved: 2021/09/30
NDC:71335-1445

Singapore Approved Products

CYMBALTA CAPSULE 60MG
Manufacturer:Lilly del Caribe, Inc. (PR01)
Form:CAPSULE
Strength:60.0 mg
Online:Yes
Approved: 2006/03/07
Approval:SIN13190P
HOVID DULOXETINE DELAYED RELEASE CAPSULE 60MG
Manufacturer:Nosch Labs Private Limited (Bulk Manufacturer), Natco Pharma Ltd (Encapsulation Site)
Form:CAPSULE, DELAYED RELEASE
Strength:60mg
Online:Yes
Approved: 2017/07/05
Approval:SIN15282P
HOVID DULOXETINE DELAYED RELEASE CAPSULE 30MG
Manufacturer:Nosch Labs Private Limited (Bulk Manufacturer), Natco Pharma Ltd (Encapsulation Site)
Form:CAPSULE, DELAYED RELEASE
Strength:30mg
Online:Yes
Approved: 2017/07/05
Approval:SIN15281P
CYMBALTA CAPSULE 30MG
Manufacturer:Lilly del Caribe, Inc. (PR01)
Form:CAPSULE
Strength:30.0 mg
Online:Yes
Approved: 2006/03/07
Approval:SIN13189P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath