FDA — authorised 30 September 1997
- Marketing authorisation holder: CEPHALON
- Status: approved
🇺🇸 Gabitril in United States
FDA authorised Gabitril on 30 September 1997
Marketing authorisations
FDA — authorised 8 May 1998
- Application: NDA020646
- Marketing authorisation holder: CEPHALON
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 4 November 2011
- Application: ANDA077555
- Marketing authorisation holder: SUN PHARM INDS
- Status: approved
FDA — authorised 16 November 2021
- Application: ANDA214816
- Marketing authorisation holder: MSN
- Status: approved
Gabitril 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 Gabitril approved in United States?
Yes. FDA authorised it on 30 September 1997; FDA authorised it on 8 May 1998; FDA authorised it on 4 November 2011.
Who is the marketing authorisation holder for Gabitril in United States?
CEPHALON holds the US marketing authorisation.