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Valproic acid

Generic Name
Valproic acid
Brand Names
Depakene, Depakote, Epival
Drug Type
Small Molecule
Chemical Formula
C8H16O2
CAS Number
99-66-1
Unique Ingredient Identifier
614OI1Z5WI

Overview

Valproic acid, or valproate, is an fatty acid derivative and anticonvulsant originally synthesized in 1881 by Beverly S. Burton. It enjoyed use as a popular organic solvent in industry and pharmaceutical manufacturing for nearly a century. In 1963, a serendipitous discovery was made by George Carraz during his investigations into the anticonvulsant effects of khelline when he found that all of his samples, dissolved in valproic acid, exerted a similar degree of anticonvulsive activity. It first received approval on February 28, 1978 from the FDA under the trade name Depakene. Since then, it has been investigated for neuroprotective, anti-manic, and anti-migraine effects. It is currently a compound of interest in the field of oncology for its anti-proliferative effects and is the subject of many clinical trials in a variety of cancer types.

Background

Valproic acid, or valproate, is an fatty acid derivative and anticonvulsant originally synthesized in 1881 by Beverly S. Burton. It enjoyed use as a popular organic solvent in industry and pharmaceutical manufacturing for nearly a century. In 1963, a serendipitous discovery was made by George Carraz during his investigations into the anticonvulsant effects of khelline when he found that all of his samples, dissolved in valproic acid, exerted a similar degree of anticonvulsive activity. It first received approval on February 28, 1978 from the FDA under the trade name Depakene. Since then, it has been investigated for neuroprotective, anti-manic, and anti-migraine effects. It is currently a compound of interest in the field of oncology for its anti-proliferative effects and is the subject of many clinical trials in a variety of cancer types.

Indication

Indicated for: 1) Use as monotherapy or adjunctive therapy in the management of complex partial seizures and simple or complex absence seizures. 2) Adjunctive therapy in the management of multiple seizure types that include absence seizures. 3) Prophylaxis of migraine headaches. 4) Acute management of mania associated with bipolar disorder. Off-label uses include: 1) Maintenance therapy for bipolar disorder. 2) Treatment for acute bipolar depression. 3) Emergency treatment of status epilepticus.

Associated Conditions

  • Bipolar Disorder (BD)
  • Complex Partial Seizure Disorder
  • Depressive Episodes
  • Migraine
  • Petit Mal Epilepsy
  • Seizure, multiple types
  • Acute Manic episode

FDA Approved Products

Valproic Acid
Manufacturer:NCS HealthCare of KY, Inc dba Vangard Labs
Route:ORAL
Strength:250 mg in 1 1
Approved: 2018/04/30
NDC:0615-8205
Valproic
Manufacturer:Aphena Pharma Solutions - Tennessee, LLC
Route:ORAL
Strength:250 mg in 1 1
Approved: 2016/06/28
NDC:43353-107
Valproic Acid
Manufacturer:ATLANTIC BIOLOGICALS CORP.
Route:ORAL
Strength:250 mg in 5 mL
Approved: 2023/01/19
NDC:17856-0792
Valproic Acid
Manufacturer:NuCare Pharmaceuticals,Inc.
Route:ORAL
Strength:250 mg in 1 1
Approved: 2022/05/20
NDC:68071-2702
VALPROIC ACID
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:250 mg in 5 mL
Approved: 2023/02/01
NDC:71335-2250

Singapore Approved Products

Sodium Valproate ADVAGEN Solution for Injection or Infusion 100mg/ml
Manufacturer:Sichuan Huiyu Pharmaceutical Co., Ltd.
Form:INJECTION, SOLUTION
Strength:100mg/ml
Online:Yes
Approved: 2024/04/25
Approval:SIN16992P
Epilim® 400 mg Powder for injection / infusion
Manufacturer:sanofi S.R.L, Chinoin Pharmaceutical and Chemical Works Private Co. Ltd (Solvent)
Form:INJECTION, POWDER, FOR SOLUTION
Strength:400 mg/vial
Online:Yes
Approved: 1990/11/23
Approval:SIN05215P
EPILIM SYRUP 200 mg/5 ml
Manufacturer:Unither Liquid Manufacturing
Form:SYRUP
Strength:200 mg/5 ml
Online:Yes
Approved: 1991/02/22
Approval:SIN05434P
VALPROATE-AFT Solution for Infusion/ Injection 100mg/ml
Manufacturer:LABIANA Pharmaceuticals
Form:INJECTION, SOLUTION
Strength:100 mg/ml
Online:Yes
Approved: 2022/11/16
Approval:SIN16642P
EPILIM CHRONO TABLET 300 mg
Manufacturer:SANOFI-SYNTHELABO LTD, Sanofi Winthrop Industrie
Form:TABLET, FILM COATED
Strength:87 mg
Online:Yes
Approved: 1995/12/16
Approval:SIN08484P

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