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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
Manufacturer:BluePoint
Route:ORAL
Strength:20 mg in 1 1
Approved: 2023/10/19
NDC:68001-413
Duloxetine
Manufacturer:Quality Care Products LLC
Route:ORAL
Strength:60 mg in 1 1
Approved: 2022/04/06
NDC:55700-628
Duloxetine
Manufacturer:REMEDYREPACK INC.
Route:ORAL
Strength:30 mg in 1 1
Approved: 2024/02/14
NDC:70518-1054
Duloxetine Delayed-Release
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:20 mg in 1 1
Approved: 2024/02/05
NDC:72162-1597
Duloxetine
Manufacturer:Zydus Pharmaceuticals (USA) Inc.
Route:ORAL
Strength:60 mg in 1 1
Approved: 2020/10/19
NDC:68382-387

Singapore Approved Products

No Singapore products found for this drug

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