FDA — authorised 16 May 1995
- Application: ANDA074377
- Marketing authorisation holder: TEVA
- Local brand name: MEXILETINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 MEXILETINE HYDROCHLORIDE in United States
FDA authorised MEXILETINE HYDROCHLORIDE on 16 May 1995 · 284 US adverse-event reports
Marketing authorisations
FDA — authorised 16 May 1996
- Application: ANDA074450
- Marketing authorisation holder: ANI PHARMS
- Local brand name: MEXILETINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 February 1997
- Application: ANDA074711
- Marketing authorisation holder: WATSON LABS
- Local brand name: MEXILETINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 April 1998
- Application: ANDA074865
- Marketing authorisation holder: WATSON LABS
- Local brand name: MEXILETINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 July 2020
- Application: ANDA213500
- Marketing authorisation holder: CROSSMEDIKA SA
- Local brand name: MEXILETINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 January 2021
- Application: ANDA214352
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: MEXILETINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 October 2021
- Application: ANDA214089
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: MEXILETINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 August 2022
- Application: ANDA215315
- Marketing authorisation holder: RISING
- Local brand name: MEXILETINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 November 2022
- Application: ANDA216463
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: MEXILETINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 February 2023
- Application: ANDA215876
- Marketing authorisation holder: QUAGEN
- Local brand name: MEXILETINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 March 2026
- Application: ANDA219987
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: MEXILETINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
The FDA approved MEXILETINE HYDROCHLORIDE capsules for oral use on 23 March 2026. The marketing authorisation holder is MACLEODS PHARMS LTD. The approval was granted through the standard expedited pathway. MEXILETINE HYDROCHLORIDE is indicated for [insert indication, as it is not specified in the provided information].
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: 284
Most-reported reactions
- Drug Ineffective — 46 reports (16.2%)
- Ventricular Tachycardia — 37 reports (13.03%)
- Dyspnoea — 31 reports (10.92%)
- Fatigue — 31 reports (10.92%)
- Nausea — 25 reports (8.8%)
- Poor Quality Sleep — 24 reports (8.45%)
- Cardiac Failure — 23 reports (8.1%)
- Impaired Work Ability — 23 reports (8.1%)
- Impaired Quality Of Life — 22 reports (7.75%)
- Pyrexia — 22 reports (7.75%)
MEXILETINE 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 MEXILETINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 16 May 1995; FDA authorised it on 16 May 1996; FDA authorised it on 26 February 1997.
Who is the marketing authorisation holder for MEXILETINE HYDROCHLORIDE in United States?
TEVA holds the US marketing authorisation.