Active substance
Atovaquone
- US FDA 11
- Health Canada 3
- US price lines 3
- NHS prices 1
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MEPRON | 750MG/5ML | suspension · oral | GLAXOSMITHKLINE LLC | Prescription | 8 Feb 1995 |
| ATOVAQUONE | 750MG/5ML | suspension · oral | AMNEAL PHARMS | Prescription | 18 Mar 2014 |
| ATOVAQUONE | 750MG/5ML | suspension · oral | CHARTWELL RX | Prescription | 28 Apr 2017 |
| ATOVAQUONE | 750MG/5ML | suspension · oral | HETERO LABS LTD III | Prescription | 11 Oct 2018 |
| ATOVAQUONE | 750MG/5ML | suspension · oral | GLENMARK SPECLT | Prescription | 21 Nov 2018 |
| ATOVAQUONE | 750MG/5ML | suspension · oral | ABHAI LLC | Prescription | 31 May 2019 |
| ATOVAQUONE | 750MG/5ML | suspension · oral | BIONPHARMA | Prescription | 30 Mar 2021 |
| ATOVAQUONE | 750MG/5ML | suspension · oral | PAI HOLDINGS | Prescription | 25 Oct 2021 |
| MEPRON | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | GLAXOSMITHKLINE LLC | Discontinued | 25 Nov 1992 |
| ATOVAQUONE | 750MG/5ML | suspension · oral | APOTEX | Discontinued | 11 Oct 2017 |
| ATOVAQUONE | 750MG/5ML | suspension · oral | LUPIN | Discontinued | 11 Sep 2018 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AURO-ATOVAQUONE | 02556618 | 750 MG / 5 ML | SUSPENSION · ORAL | AURO PHARMA INC |
| GLN-ATOVAQUONE | 02528495 | 750 MG / 5 ML | SUSPENSION · ORAL | GLENMARK PHARMACEUTICALS CANADA INC. |
| MEPRON | 02217422 | 750 MG / 5 ML | SUSPENSION · ORAL | GLAXOSMITHKLINE INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ATOVAQUONE 750 MG/5 ML SUSP | $0.76684 | per ML | 23 Sep 2026 |
| US NADAC | ATOVAQUONE 750 MG/5 ML SUSP CUP | $0.76684 | per ML | 23 Sep 2026 |
| US NADAC | ATOVAQUONE 750 MG/5 ML SUSPENSION CUP | $0.76684 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Atovaquone 750mg/5ml oral suspension sugar free | £486.37 | 226 ml | 1 Oct 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 10 Jun 2026 MALARONE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 20 Mar 2026 MEPRON — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Combinations containing Atovaquone
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.