FDA approved Gabapentin Capsules (gabapentin) for Postherpetic Neuralgia and Partial Onset SeizuresFDA approved a new generic version of the drug gabapentin for nerve pain and seizures

FDA From the archive Source published May 14, 2018 Summary added April 9, 2026 DOI ↗ Editorial oversight: Dr. Ji-eun Park, MD · Brain, Mind & Pain

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Key Takeaway

Consider renal function and gradual titration when prescribing gabapentin capsules.

The FDA has approved Gabapentin Capsules, USP, a generic formulation of gabapentin, for two established neurological indications. The approval covers management of postherpetic neuralgia in adults and adjunctive therapy for partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.

This approval provides clinicians with another generic treatment option for neuropathic pain and seizure disorders. For postherpetic neuralgia, dosing follows a titration schedule starting at 300 mg on day one, increasing to 600 mg/day on day two, and 900 mg/day on day three, with potential titration up to 1800 mg/day based on pain relief needs. For epilepsy, dosing varies by age, with adult patients starting at 300 mg three times daily and pediatric dosing based on weight.

The availability of this generic formulation may increase access to gabapentin therapy while maintaining the established dosing protocols and renal adjustment requirements outlined in the prescribing information.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Not reported in label.

Indication & Patient Population

Gabapentin Capsules, USP are indicated for: Management of postherpetic neuralgia in adults. Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.

Dosing & Administration

For Postherpetic Neuralgia in adults: Initiate on Day 1 as a single 300 mg dose, Day 2 as 600 mg/day (300 mg two times a day), and Day 3 as 900 mg/day (300 mg three times a day). Titrate up as needed to 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over 1800-3600 mg/day, but additional benefit above 1800 mg/day was not demonstrated.

For Epilepsy with Partial Onset Seizures: Patients ≥12 years: starting dose 300 mg three times daily; may titrate to 600 mg three times daily. Doses up to 2400 mg/day well tolerated long-term; 3600 mg/day tolerated short-term in small numbers. Patients 3-11 years: starting dose 10-15 mg/kg/day in three divided doses; recommended maintenance dose: 40 mg/kg/day (ages 3-4) or 25-35 mg/kg/day (ages 5-11) in three divided doses, titrated over ~3 days. Dosages up to 50 mg/kg/day well tolerated long-term.

Renal adjustment required for patients ≥12 years (see table in label). Use Cockcroft-Gault equation to estimate creatinine clearance. Not studied in patients <12 years with renal impairment. Elderly patients may need dose adjustment based on renal function. Administer orally with/without food. Swallow capsules whole with water. Reduce/discontinue/substitute gradually over ≥1 week.

Key Clinical Trial Data

For postherpetic neuralgia: Efficacy demonstrated over 1800-3600 mg/day range with comparable effects; additional benefit above 1800 mg/day not demonstrated. For epilepsy: Doses up to 2400 mg/day well tolerated in long-term studies; 3600 mg/day tolerated short-term in small numbers. Pediatric doses up to 50 mg/kg/day well tolerated in long-term study.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

The U.S. Food and Drug Administration (FDA) has approved a new generic version of the drug gabapentin. This drug is used to treat two main conditions. The first is a specific type of nerve pain that can follow a shingles infection, called postherpetic neuralgia. The second is as an add-on treatment for certain types of seizures in people with epilepsy.

This approval is for a generic capsule, which is often a lower-cost version of a brand-name drug. It is approved for adults with nerve pain and for adults and children aged 3 and older with epilepsy. The approval gives doctors and patients another treatment option that follows the same established dosing plans.

For patients, this news means there may be increased access to this medication. However, it is very important to understand that this is not a new drug, but a new version of an existing one. The approval does not change how the drug works or its safety profile.

The most important step for anyone currently taking gabapentin or considering it is to speak with their healthcare provider. Only a doctor who knows your full medical history can determine if this specific generic version is right for your individual treatment plan.

What this means for you:

This is a new generic option for an existing medication. Talk to your doctor about what it means for you.

Study Details

Study typeFda approval

PublishedMay 2018

View Original Abstract ↓

1 INDICATIONS AND USAGE Gabapentin Capsules, USP are indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin Capsules, USP are indicated for Postherpetic neuralgia in adults (1) Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)

FDA approved Gabapentin Capsules (gabapentin) for Postherpetic Neuralgia and Partial Onset SeizuresFDA approved a new generic version of the drug gabapentin for nerve pain and seizures

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