Active substance
Zileuton
- US FDA 8
- US price lines 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ZILEUTON | 600MG | tablet, extended release · oral | RISING | Prescription | 17 Mar 2017 |
| ZILEUTON | 600MG | tablet, extended release · oral | STRIDES PHARMA INTL | Prescription | 16 Dec 2019 |
| ZILEUTON | 600MG | tablet, extended release · oral | AIZANT | Prescription | 23 Oct 2020 |
| ZILEUTON | 600MG | tablet, extended release · oral | ANNORA PHARMA | Prescription | 11 Oct 2022 |
| ZYFLO | 300MG; 600MG | tablet · oral | CHIESI | Discontinued | 9 Dec 1996 |
| ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet, extended release · oral | CHIESI | Discontinued | 30 May 2007 |
| ZILEUTON | 600MG | tablet, extended release · oral | LUPIN | Discontinued | 5 Nov 2019 |
| ZILEUTON | 600MG | tablet, extended release · oral | TEVA PHARMS USA | Discontinued | 3 May 2022 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ZILEUTON ER 600 MG TABLET | $2.04927 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 31 Dec 2018 ZYFLO CR — safety-related labeling change
Labeling sections changed: Use in Specific Populations
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.