FDA — authorised 4 December 2019
- Application: ANDA208014
- Marketing authorisation holder: SUN PHARM
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 FINGOLIMOD HYDROCHLORIDE in United States
FDA authorised FINGOLIMOD HYDROCHLORIDE on 4 December 2019 · 600 US adverse-event reports
Marketing authorisations
FDA — authorised 4 December 2019
- Application: ANDA207979
- Marketing authorisation holder: BIOCON LTD
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 May 2020
- Application: ANDA207933
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 June 2020
- Application: ANDA207985
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 June 2020
- Application: ANDA207971
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 July 2020
- Application: ANDA208008
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 October 2020
- Application: ANDA207994
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 October 2020
- Application: ANDA207991
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 December 2020
- Application: ANDA207993
- Marketing authorisation holder: APOTEX
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 December 2020
- Application: ANDA208004
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 January 2021
- Application: ANDA208005
- Marketing authorisation holder: MYLAN
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 March 2021
- Application: ANDA208000
- Marketing authorisation holder: DR REDDYS
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 November 2021
- Application: ANDA207939
- Marketing authorisation holder: HEC PHARM CO LTD
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 November 2021
- Application: ANDA212152
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 September 2022
- Application: ANDA208003
- Marketing authorisation holder: PRINSTON INC
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 December 2023
- Application: ANDA207945
- Marketing authorisation holder: EZRA VENTURES
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 February 2024
- Application: ANDA207983
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 April 2026
- Application: ANDA207974
- Marketing authorisation holder: ALEMBIC
- Local brand name: FINGOLIMOD HYDROCHLORIDE
- Indication: CAPSULE — 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: 600
Most-reported reactions
- Multiple Sclerosis Relapse — 101 reports (16.83%)
- Fatigue — 87 reports (14.5%)
- Gait Disturbance — 61 reports (10.17%)
- Headache — 57 reports (9.5%)
- Hypoaesthesia — 55 reports (9.17%)
- Pain — 55 reports (9.17%)
- Multiple Sclerosis — 50 reports (8.33%)
- Dizziness — 49 reports (8.17%)
- Lymphocyte Count Decreased — 45 reports (7.5%)
- Fall — 40 reports (6.67%)
FINGOLIMOD HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is FINGOLIMOD HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 4 December 2019; FDA authorised it on 4 December 2019; FDA authorised it on 18 May 2020.
Who is the marketing authorisation holder for FINGOLIMOD HYDROCHLORIDE in United States?
SUN PHARM holds the US marketing authorisation.