Active substance
Bepotastine
- US FDA 5
- Health Canada 1
- US price lines 3
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| BEPREVE | 1.5% | solution/drops · ophthalmic | BAUSCH AND LOMB INC | Prescription | 8 Sep 2009 |
| BEPOTASTINE BESILATE | 1.5% | solution/drops · ophthalmic | MYLAN | Prescription | 18 Mar 2019 |
| BEPOTASTINE BESILATE | 1.5% | solution/drops · ophthalmic | ALEMBIC | Prescription | 5 Apr 2023 |
| BEPOTASTINE BESILATE | 1.5% | solution/drops · ophthalmic | SOMERSET THERAPS LLC | Prescription | 14 Aug 2024 |
| BEPOTASTINE BESILATE | 1.5% | solution/drops · ophthalmic | APOTEX | Discontinued | 5 Mar 2019 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| BEPREVE | 02456532 | 1.5 % / W/V | SOLUTION · OPHTHALMIC | BAUSCH & LOMB INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | BEPOTASTINE 1.5% EYE DROP | $10.48665 | per ML | 23 Sep 2026 |
| US NADAC | BEPOTASTINE 1.5% EYE DROP | $8.28568 | per ML | 23 Sep 2026 |
| US NADAC | BEPREVE 1.5% EYE DROPS | $55.93567 | per ML | 18 Mar 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 9 Feb 2018 BEPREVE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.