Regulatory PathRegulatory requirements compared

Active substance

Rifabutin

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
MYCOBUTIN150MGcapsule · oralPFIZERPrescription23 Dec 1992
RIFABUTIN150MGcapsule · oralNOVITIUM PHARMAPrescription17 Dec 2021
RIFABUTIN150MGcapsule · oralPHARMAZONEPrescription19 Mar 2026
RIFABUTIN150MGcapsule · oralZYDUS LIFESCIENCESPrescription21 Aug 2026
RIFABUTIN150MGcapsule · oralLUPINDiscontinued24 Feb 2014

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
MYCOBUTIN02063786150 MGCAPSULE · ORALPFIZER CANADA ULC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACRIFABUTIN 150 MG CAPSULE$8.13629per EA23 Sep 2026
NHS Drug TariffRifabutin 150mg capsules£90.3830 capsule1 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.

WHO WHO Model List of Essential Medicines (2025)

  • 6.2.5. Antituberculosis medicines · core
    Tuberculosis
    Oral > Solid: 150 mg

Safety signals and safety-related labeling changes

All safety entries for rifabutin →

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.