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Treats active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis. ANDA 217042, held by Macleods Pharms. Rifapentine.
As of Nov 15, 2026, ANDA 217042 (Rifapentine), held by Macleods Pharms, was first approved by FDA on Jun 23, 2026, with 0 approved supplements and 0 published complete response letters.
First approved: Jun 23, 2026
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Rifapentine tablets are a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible.
Rifapentine tablets are indicated for the treatment of latent tuberculosis infection (LTBI) caused by M. tuberculosis in combination with isoniazid in patients 2 years of age and older at high risk of progression to TB disease.
See Full Prescribing Information for Limitations of Use. ( 1.1, 1.2 ) 1.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
