FDA — authorised 30 December 1993
- Application: NDA020235
- Marketing authorisation holder: VIATRIS
- Local brand name: NEURONTIN
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Gapabentin in United States
FDA authorised Gapabentin on 30 December 1993 · 15 US adverse-event reports
Marketing authorisations
FDA — authorised 9 October 1998
- Application: NDA020882
- Marketing authorisation holder: VIATRIS
- Local brand name: NEURONTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 2000
- Application: NDA021129
- Marketing authorisation holder: VIATRIS
- Local brand name: NEURONTIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 24 May 2002
- Application: NDA021423
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NEURONTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 May 2002
- Application: NDA021397
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NEURONTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 May 2002
- Application: NDA021424
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NEURONTIN
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 15
Most-reported reactions
- Pneumonia — 3 reports (20%)
- Death — 2 reports (13.33%)
- Dizziness — 2 reports (13.33%)
- Nasal Congestion — 2 reports (13.33%)
- Abdominal Pain — 1 report (6.67%)
- Acute Hepatic Failure — 1 report (6.67%)
- Acute Kidney Injury — 1 report (6.67%)
- Adverse Event — 1 report (6.67%)
- Anxiety — 1 report (6.67%)
- Asthenia — 1 report (6.67%)
Gapabentin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Gapabentin approved in United States?
Yes. FDA authorised it on 30 December 1993; FDA authorised it on 9 October 1998; FDA authorised it on 2 March 2000.
Who is the marketing authorisation holder for Gapabentin in United States?
VIATRIS holds the US marketing authorisation.