FDA — authorised 6 April 2011
- Marketing authorisation holder: XENOPORT INC
- Status: approved
🇺🇸 Horizant in United States
FDA authorised Horizant on 6 April 2011
Marketing authorisations
FDA — authorised 2 April 2020
- Application: NDA022399
- Marketing authorisation holder: AZURITY
- Indication: Labeling
- Status: approved
FDA
- Application: ANDA220420
- Marketing authorisation holder: ANNORA PHARMA PRIVATE LIMITED
- Local brand name: GABAPENTIN ENACARBIL
- Indication: TABLET, EXTENDED RELEASE
- Status: approved
Horizant in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Horizant approved in United States?
Yes. FDA authorised it on 6 April 2011; FDA authorised it on 2 April 2020; FDA has authorised it.
Who is the marketing authorisation holder for Horizant in United States?
XENOPORT INC holds the US marketing authorisation.