Active substance
Tavaborole
- US FDA 10
- US price lines 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| TAVABOROLE | 5% | solution · topical | ENCUBE | Prescription | 13 Oct 2020 |
| TAVABOROLE | 5% | solution · topical | ALEMBIC | Prescription | 21 Oct 2020 |
| TAVABOROLE | 5% | solution · topical | CHARTWELL RX | Prescription | 3 Feb 2021 |
| TAVABOROLE | 5% | solution · topical | ZYDUS LIFESCIENCES | Prescription | 10 Apr 2023 |
| KERYDIN | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · topical | ANACOR PHARMS INC | Discontinued | 7 Jul 2014 |
| TAVABOROLE | 5% | solution · topical | PADAGIS US | Discontinued | 13 Oct 2020 |
| TAVABOROLE | 5% | solution · topical | AMNEAL | Discontinued | 25 Nov 2020 |
| TAVABOROLE | 5% | solution · topical | LUPIN | Discontinued | 8 Feb 2021 |
| TAVABOROLE | 5% | solution · topical | CIPLA | Discontinued | 9 Feb 2021 |
| TAVABOROLE | 5% | solution · topical | SUN PHARMA CANADA | Discontinued | 7 May 2021 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | TAVABOROLE 5% TOPICAL SOLUTION | $3.39012 | per ML | 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 30 Jul 2018 KERYDIN — safety-related labeling change
Labeling sections changed: Adverse Reactions; 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.