VALPROATE SODIUM · Fresenius Kabi
Valproate sodium injection is an intravenous alternative for patients who are temporarily unable to receive oral valproate medications. It is indicated for the treatment of complex partial seizures, simple and complex absence seizures, and multiple seizure types that include absence seizures. The medication is utilized as both monotherapy and adjunctive therapy depending on the specific seizure type and clinical presentation. Use is restricted in pregnant women and women of childbearing potential due to risks of major congenital malformations and neurodevelopmental disorders.
How VALPROATE SODIUM Works
Valproate sodium exists as the valproate ion within the bloodstream. Although the exact mechanisms of its therapeutic effects have not been fully established, its activity in treating epilepsy is suggested to be related to neurotransmitter levels. Specifically, the drug is thought to work by increasing the concentrations of gamma-aminobutyric acid (GABA) in the brain.
Details
- Status
- Prescription
- First Approved
- 1996-12-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VALPROATE SODIUM Approval History
What VALPROATE SODIUM Treats
4 indicationsVALPROATE SODIUM is approved for 4 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Complex partial seizures (monotherapy and adjunctive therapy)
- Simple absence seizures (sole and adjunctive therapy)
- Complex absence seizures (sole and adjunctive therapy)
- Multiple seizure types that include absence seizures (adjunctive therapy)
VALPROATE SODIUM Boxed Warning
LIFE THREATENING ADVERSE REACTIONS WARNING: LIFE THREATENING ADVERSE REACTIONS See full prescribing information for complete boxed warning. • Hepatotoxicity, including fatalities, usually during the first 6 months of treatment. Children under the age of two years and patients with mitochondrial disorders are at higher risk. Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter ( 5.1 ) • Fetal Risk, particularly neural tube defects, other ...
WARNING: LIFE THREATENING ADVERSE REACTIONS WARNING: LIFE THREATENING ADVERSE REACTIONS See full prescribing information for complete boxed warning. • Hepatotoxicity, including fatalities, usually during the first 6 months of treatment. Children under the age of two years and patients with mitochondrial disorders are at higher risk. Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter ( 5.1 ) • Fetal Risk, particularly neural tube defects, other major malformations, and decreased IQ ( 5.2 , 5.3 , 5.4 ) • Pancreatitis, including fatal hemorrhagic cases ( 5.5 ) Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Serum liver tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months [see Warnings and Precautions ( 5.1 )] . Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease. When valproate sodium injection is used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. The incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups. Patients with Mitochondrial Disease: There is an increased risk of valproate-induced acute liver failu
VALPROATE SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Fresenius Kabi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06081283 results posted | 23-0157 | Ph 4 | terminated | Antiseizure Medication in Seizure Networks at Early Acute Brain Injury |
| NCT04698525 results posted | 74-19 | Ph 3 | completed | Comparative Study Between Valproate and Memantine in the Prophylactic Management of Episodic Migraine. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VALPROATE SODIUM FDA Label Details
Indications & Usage
Valproate sodium injection is indicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily not feasible in the following conditions: • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures 1.1 Epilepsy Valproate sodium injection is indicated as an intravenous alternative in patients for whom oral administration of valproate products is temporarily not feasible in the following conditions: Valproate sod...
WARNING: LIFE THREATENING ADVERSE REACTIONS WARNING: LIFE THREATENING ADVERSE REACTIONS See full prescribing information for complete boxed warning. • Hepatotoxicity, including fatalities, usually during the first 6 months of treatment. Children under the age of two years and patients with mitochond...
Looking for the branded version?
DEPACON
Full clinical data, patents, trials, and competitive landscape for valproate sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.