FDA — authorised 1 October 1999
- Marketing authorisation holder: PFIZER
- Status: approved
🇺🇸 Tikosyn in United States
FDA authorised Tikosyn on 1 October 1999
Marketing authorisations
FDA — authorised 1 October 1999
- Application: NDA020931
- Marketing authorisation holder: PFIZER
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA — authorised 6 June 2016
- Application: ANDA207058
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: DOFETILIDE
- Indication: CAPSULE — ORAL
- Status: approved
The FDA approved Tikosyn for its labelled indication on 2025-02-24. DR REDDYS LABS SA is the marketing authorisation holder. The approval was granted through the standard expedited pathway.
FDA — authorised 26 March 2018
- Application: ANDA207746
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Status: approved
FDA — authorised 10 April 2018
- Application: ANDA208625
- Marketing authorisation holder: BIONPHARMA
- Local brand name: DOFETILIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 October 2018
- Application: ANDA210466
- Marketing authorisation holder: SUN PHARM
- Local brand name: DOFETILIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 January 2019
- Application: ANDA210740
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DOFETILDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 December 2019
- Application: ANDA211223
- Marketing authorisation holder: PRINSTON INC
- Local brand name: DOFETILIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 December 2019
- Application: ANDA212410
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: DOFETILIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 January 2020
- Application: ANDA213220
- Marketing authorisation holder: MSN
- Local brand name: DOFETILIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 June 2020
- Application: ANDA213338
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: DOFETILIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 October 2021
- Application: ANDA212750
- Marketing authorisation holder: GRANULES
- Local brand name: DOFETILIDE
- Indication: CAPSULE — ORAL
- Status: approved
The FDA approved Tikosyn for its labelled indication on 2024-04-30. The marketing authorisation holder is GRANULES. This approval was granted under the standard expedited pathway.
FDA — authorised 14 April 2022
- Application: ANDA215323
- Marketing authorisation holder: RK PHARMA
- Local brand name: DOFETILIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 April 2022
- Application: ANDA210018
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: DOFETILIDE
- Indication: CAPSULE — ORAL
- Status: approved
Tikosyn in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Tikosyn approved in United States?
Yes. FDA authorised it on 1 October 1999; FDA authorised it on 1 October 1999; FDA authorised it on 6 June 2016.
Who is the marketing authorisation holder for Tikosyn in United States?
PFIZER holds the US marketing authorisation.