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Pretomanid FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 2, 2019.

FDA Approved: Yes (First approved August 14, 2019)
Generic name: pretomanid
Dosage form: Tablets
Company: TB Alliance
Treatment for: Tuberculosis, Resistant

Pretomanid is a nitroimidazooxazine antimycobacterial indicated for use in combination with bedaquiline and linezolid (the BPaL regimen) for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).

Limitations of Use:



Pretomanid Tablets used in combination with bedaquiline and linezolid are contraindicated in patients for whom bedaquiline and/or linezolid is contraindicated.

Warnings and Precautions

Adverse Reactions
Most common adverse reactions (≥10%) are peripheral neuropathy, acne, anemia, nausea, vomiting, headache, increased transaminases, dyspepsia, decreased appetite, rash, pruritus, abdominal pain, pleuritic pain, increased gamma-glutamyltransferase, lower respiratory tract infection, hyperamylasemia, hemoptysis, back pain, cough, visual impairment, hypoglycemia, abnormal loss of weight, and diarrhea.

Development timeline for pretomanid

Aug 14, 2019Approval FDA Approves Pretomanid for Highly Drug-Resistant Forms of Tuberculosis
Jun  6, 2019FDA Advisory Committee Votes Favorably on the Question of the Effectiveness and Safety of Pretomanid in Combination with Bedaquiline and Linezolid for Treatment of Highly Drug-Resistant Forms of Tuberculosis
Mar  8, 2019TB Medicine Pretomanid Enters Regulatory Review Process in the United States

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.