FDA — authorised 17 March 2017
- Application: ANDA204929
- Marketing authorisation holder: RISING
- Local brand name: ZILEUTON
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 ZILEUTON in United States
FDA authorised ZILEUTON on 17 March 2017 · 145 US adverse-event reports
Marketing authorisations
FDA — authorised 5 November 2019
- Application: ANDA211972
- Marketing authorisation holder: LUPIN
- Local brand name: ZILEUTON
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 October 2020
- Application: ANDA211390
- Marketing authorisation holder: AIZANT
- Local brand name: ZILEUTON
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 May 2022
- Application: ANDA211043
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ZILEUTON
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 October 2022
- Application: ANDA215742
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: ZILEUTON
- Indication: TABLET, EXTENDED RELEASE — 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: 145
Most-reported reactions
- Drug Ineffective — 27 reports (18.62%)
- Asthma — 26 reports (17.93%)
- Dyspnoea — 15 reports (10.34%)
- Off Label Use — 15 reports (10.34%)
- Nausea — 13 reports (8.97%)
- Pneumonia — 12 reports (8.28%)
- Condition Aggravated — 11 reports (7.59%)
- Dizziness — 9 reports (6.21%)
- Drug Ineffective For Unapproved Indication — 9 reports (6.21%)
- Chronic Obstructive Pulmonary Disease — 8 reports (5.52%)
ZILEUTON 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 ZILEUTON approved in United States?
Yes. FDA authorised it on 17 March 2017; FDA authorised it on 5 November 2019; FDA authorised it on 23 October 2020.
Who is the marketing authorisation holder for ZILEUTON in United States?
RISING holds the US marketing authorisation.