FDA approves first generic rifapentine for tuberculosis treatment, prevention in 12 years and older

The FDA has approved the first generic version of rifapentine tablets, expanding access to a key component of treatment regimens for both active pulmonary tuberculosis (TB) and latent tuberculosis infection (LTBI).

According to the agency, the generic rifapentine tablets are approved for use in combination with one or more antituberculosis medications to which the infecting isolate is susceptible for the treatment of active pulmonary TB caused by Mycobacterium tuberculosis in patients aged 12 years and older. The medication is also approved for the treatment of latent tuberculosis infection caused by M tuberculosis when used in combination with isoniazid in patients aged 2 years and older who are at high risk of progressing to active TB disease.

The approval represents the first generic alternative to Priftin (rifapentine), a rifamycin-class antimicrobial that has become an important component of several TB treatment and prevention regimens. The availability of a generic product may help improve access to recommended therapies, particularly in populations at elevated risk for TB infection and disease progression.

Tuberculosis remains a significant public health concern worldwide. While active TB disease requires multidrug treatment to prevent disease progression, transmission, and the development of resistance, treatment of latent infection is a key strategy for reducing future cases of active disease. Pediatric patients, especially young children exposed to infectious TB, are among the populations at increased risk for progression from latent infection to active disease.

The FDA noted that the prescribing information for generic rifapentine tablets includes the same contraindications, warnings, and precautions as the reference product. "The prescribing information for the generic rifapentine tablets includes the same contraindications, warnings, and precautions as Priftin."

Rifapentine tablets are contraindicated in patients with a known history of hypersensitivity to any rifamycin. Clinicians should also be aware of several important safety considerations associated with the medication. "Rifapentine carries warnings such as the risk of hepatotoxicity, hypersensitivity and related reactions, severe cutaneous adverse reactions, relapse in treatment of active pulmonary tuberculosis, and drug interactions."

As with other rifamycin agents, rifapentine may cause discoloration of body fluids and tissues. The FDA noted that "Rifapentine tablets may produce a red-orange discoloration of body tissues and fluids."

For patients receiving rifapentine-containing regimens for active pulmonary TB, the most commonly reported adverse reactions occurring in at least 3% of patients include anemia, lymphopenia, hemoptysis, neutropenia, cough, thrombocytosis, increased sweating, elevated alanine aminotransferase and aspartate aminotransferase levels, back pain, rash, anorexia, arthralgia, increased blood urea, and headache.

Among patients receiving rifapentine in combination with isoniazid for latent tuberculosis infection, hypersensitivity reactions were the most common adverse event reported at a frequency of 3% or greater.

For pediatricians, the approval provides an additional treatment option for children and adolescents who meet age and indication requirements. The approval covers treatment of latent tuberculosis infection in children as young as 2 years of age who are at high risk of progression to active disease, as well as treatment of active pulmonary TB in adolescents aged 12 years and older when used as part of an appropriate multidrug regimen.

The FDA advised that healthcare professionals review the full prescribing information for complete dosing recommendations, contraindications, warnings, precautions, and drug interaction information before initiating therapy.

Reference

FDA Center for Drug Evaluation and Research. FDA Approves First Generic of Priftin (rifapentine) tablets. FDA. Press release. June 23, 2025. Accessed June 23, 2026.