FDA approves the first generic rifapentine tablets for active pulmonary tuberculosis and latent TB infection, expanding access to a WHO-recommended treatment and prevention therapy.
Written By: Disha Jadhao, BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has approved the first generic version of Priftin (rifapentine) tablets, marking an important step toward improving access to tuberculosis (TB) treatment and prevention in the United States.
The generic rifapentine tablets are approved for use in combination with other anti-tuberculosis medicines for the treatment of active pulmonary tuberculosis caused by Mycobacterium tuberculosis in patients aged 12 years and older. The drug is also approved for the treatment of latent tuberculosis infection (LTBI) when used with isoniazid in patients aged 2 years and older who are at high risk of progressing to active TB disease.
The approval was granted through the FDA’s Abbreviated New Drug Application (ANDA) pathway, which allows generic medicines to enter the market after demonstrating equivalence to the reference listed drug. The product will be included in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, where healthcare professionals and pharmacists can review therapeutic equivalence information.
The approval introduces a lower-cost alternative to the branded product and aligns with the FDA’s broader efforts to expand generic drug availability. It also supports the agency’s Drug Competition Action Plan, which seeks to increase market competition, improve patient access to essential medicines, and help reduce healthcare costs.
About Rifapentine and Its Role in Tuberculosis Care
Rifapentine belongs to the rifamycin class of antibiotics. It works by inhibiting bacterial RNA synthesis, preventing Mycobacterium tuberculosis from replicating and spreading within the body.
Tuberculosis remains one of the world’s leading infectious disease threats. While active TB requires multidrug treatment to eliminate infection and prevent resistance, latent TB infection can persist silently for years before progressing to active disease. Effective treatment of latent infection remains a critical public health strategy for reducing future TB cases.
Rifapentine is included in several World Health Organization (WHO)-recommended regimens for tuberculosis treatment and prevention, highlighting its importance in global TB control efforts. In the United States, treatment of latent tuberculosis infection remains a cornerstone of the Centers for Disease Control and Prevention’s strategy to eliminate TB.
Rifapentine-based preventive regimens have helped shorten treatment duration and improve adherence. One widely used regimen, known as 3HP, combines once-weekly rifapentine with isoniazid for 12 weeks and has demonstrated higher treatment completion rates than traditional 6- to 9-month isoniazid monotherapy.
Safety Profile Mirrors Reference Product
The FDA-approved generic carries the same prescribing information, contraindications, warnings, and precautions as the branded product, Priftin.
Rifapentine is contraindicated in patients with a known hypersensitivity to rifamycins. Key safety warnings include hepatotoxicity, hypersensitivity reactions, severe cutaneous adverse reactions, treatment failure or relapse in active pulmonary TB, and clinically significant drug-drug interactions.
As a potent inducer of hepatic cytochrome P450 enzymes, rifapentine can reduce blood concentrations of several commonly used medicines, including antiretroviral therapies, oral contraceptives, anticoagulants, and other drugs metabolized through these pathways. Healthcare providers should carefully review concomitant medications before initiating treatment.
Patients should also be advised that rifapentine may cause a harmless red-orange discoloration of body fluids and tissues, including urine, sweat, tears, and saliva.
In active pulmonary TB treatment regimens, the most commonly reported adverse reactions include anemia, lymphopenia, hemoptysis, neutropenia, cough, thrombocytosis, increased sweating, elevated liver enzymes (ALT and AST), back pain, rash, anorexia, arthralgia, increased blood urea levels, and headache.
For latent tuberculosis infection regimens, hypersensitivity reactions were the most frequently reported adverse events.
What This Means for Patients and Public Health
Priftin has been the primary branded rifapentine product available in the U.S. market. Approval of the first generic version introduces direct competition and could help reduce treatment costs and improve patient access to recommended TB treatment and prevention regimens.
Broader availability of rifapentine may strengthen efforts to identify and treat latent TB infections before they progress to active disease, supporting both individual patient outcomes and public health goals. Increased access to shorter rifapentine-based regimens could improve treatment completion, reduce future TB transmission, and support ongoing TB elimination efforts.
Healthcare professionals are advised to review the full prescribing information for detailed dosing recommendations, safety guidance, and drug interaction considerations. The FDA also recommends consulting the Orange Book and contacting manufacturers directly for information on product availability.
Reference
About the Writer
Disha Sanjay Jadhao (LinkedIn) is a pharmacy graduate and healthcare writer with a strong interest in clinical documentation and simplifying healthcare information for better reader understanding. She is enthusiastic, adaptable, and eager to take on new challenges while contributing to clear, accurate, and engaging medical and pharmaceutical content.
