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Pretomanid Approval Status

FDA Approved: No
Generic name: pretomanid
Company: TB Alliance
Treatment for: Tuberculosis, Resistant

Pretomanid is a nitroimidazooxazine in development for use in combination with bedaquiline and linezolid (the BPaL regimen) for the treatment of extensively drug-resistant (XDR) tuberculosis (TB), treatment intolerant multidrug-resistant (MDR) TB, and treatment non-responsive MDR-TB.

Development Status and FDA Approval Process for pretomanid

DateArticle
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

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