Regulatory PathRegulatory requirements compared

Active substance

Rifapentine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
PRIFTIN150MGtablet · oralSANOFI AVENTIS USPrescription22 Jun 1998
RIFAPENTINE150MGtablet · oralMACLEODS PHARMSPrescription23 Jun 2026

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPRIFTIN 150 MG TABLET$4.82801per EA23 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.

WHO WHO Model List of Essential Medicines (2025)

  • 6.2.5. Antituberculosis medicines · core
    Latent tuberculosis; Tuberculosis
    Oral > Solid > dispersible tablet: 150 mg (EMLc) | Oral > Solid > tablet: 150 mg; 300 mg

Safety signals and safety-related labeling changes

  • US FDA 27 Jan 2026 PRIFTIN — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for rifapentine →

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.