FDA — authorised 28 October 2008
- Application: NDA022254
- Marketing authorisation holder: UCB INC
- Local brand name: VIMPAT
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Vimpat in United States
FDA authorised Vimpat on 28 October 2008
Marketing authorisations
FDA — authorised 28 October 2008
- Application: NDA022253
- Marketing authorisation holder: UCB INC
- Local brand name: VIMPAT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 April 2010
- Application: NDA022255
- Marketing authorisation holder: UCB INC
- Local brand name: VIMPAT
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 March 2022
- Application: ANDA208308
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: LACOSAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 March 2022
- Application: ANDA204857
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: LACOSAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 March 2022
- Application: ANDA205237
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: LACOSAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 March 2022
- Application: ANDA204787
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: LACOSAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 March 2022
- Application: ANDA214695
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: LACOSAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2022
- Application: ANDA214301
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 31 May 2022
- Application: ANDA209301
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 June 2022
- Application: ANDA209465
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
The FDA approved Vimpat, a medication for the treatment of epilepsy, on 2025-07-21. The marketing authorisation was granted to ZYDUS PHARMS under the standard expedited pathway. The approval was based on the drug's labeling, which outlines its indications and usage.
FDA — authorised 26 August 2022
- Application: ANDA216151
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 19 September 2022
- Application: ANDA215628
- Marketing authorisation holder: GLAND
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 26 September 2022
- Application: ANDA206355
- Marketing authorisation holder: APOTEX
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 5 January 2023
- Application: ANDA204855
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: LACOSAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 February 2023
- Application: ANDA216461
- Marketing authorisation holder: KANCHAN HLTHCARE
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 9 February 2023
- Application: ANDA215979
- Marketing authorisation holder: MSN
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 4 May 2023
- Application: NDA216185
- Marketing authorisation holder: AUCTA
- Local brand name: MOTPOLY XR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 December 2023
- Application: ANDA215379
- Marketing authorisation holder: MSN
- Status: approved
FDA — authorised 13 February 2024
- Application: ANDA217311
- Marketing authorisation holder: HAINAN POLY
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 25 March 2024
- Application: ANDA217718
- Marketing authorisation holder: DR REDDYS
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 27 March 2024
- Application: ANDA204839
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 May 2024
- Application: ANDA215154
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 4 September 2024
- Application: ANDA213109
- Marketing authorisation holder: UNICHEM
- Local brand name: LACOSAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 October 2024
- Application: ANDA214960
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Status: approved
FDA — authorised 14 November 2024
- Application: ANDA218464
- Marketing authorisation holder: ACELLA
- Status: approved
FDA — authorised 23 May 2025
- Application: ANDA218706
- Marketing authorisation holder: WESTMINSTER PHARMS
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 21 January 2026
- Application: ANDA220268
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 29 January 2026
- Application: ANDA220386
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: LACOSAMIDE
- Indication: SOLUTION — ORAL
- Status: approved
Vimpat 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 Vimpat approved in United States?
Yes. FDA authorised it on 28 October 2008; FDA authorised it on 28 October 2008; FDA authorised it on 20 April 2010.
Who is the marketing authorisation holder for Vimpat in United States?
UCB INC holds the US marketing authorisation.