What is the generic name?

PRETOMANID

What is the Trade Name for PRETOMANID?

Pretomanid

What are the Indications for PRETOMANID?

• 1 INDICATIONS AND USAGE Limited Population: Pretomanid Tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients. Limitations of Use: ‚Ä¢ Pretomanid Tablets are not indicated in patients with the following conditions: o Drug-sensitive (DS) tuberculosis o Latent infection due to Mycobacterium tuberculosis. o Extra-pulmonary infection due to Mycobacterium tuberculosis. o MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy. ‚Ä¢ Safety and effectiveness of Pretomanid Tablets have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen [see Dosage and Administration (2.2) ] . Limited Population: Pretomanid Tablet is an antimycobacterial indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug‚Äëresistant (MDR) tuberculosis (TB). Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients. ( 1 ) Limitations of Use ( 1 ): ‚Ä¢ Pretomanid Tablets are not indicated for patients with: ‚Ä¢ Drug-sensitive (DS) tuberculosis ‚Ä¢ Latent infection due to Mycobacterium tuberculosis ‚Ä¢ Extra-pulmonary infection due to Mycobacterium tuberculosis ‚Ä¢ MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy ‚Ä¢ Safety and effectiveness of Pretomanid Tablets have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen.

References: https://open.fda.gov/