Pretomanid Tablets and Sodium Iodide I 131 Capsules

• Generic Name: pretomanid
• Dosage Forms: tablet
• Other Brand Names:

Limited Population: Pretomanid 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-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.

Pretomanid is not indicated for patients with: drug-sensitive (DS) tuberculosis, latent infection due to Mycobacterium tuberculosis, extrapulmonary infection due to M. tuberculosis, or MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy.

Safety and effectiveness of pretomanid have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen.

• Generic Name: sodium iodide i-123
• Dosage Forms: capsule, gelatin coated, capsule
• Other Brand Names: Anasept, Anasept Cleanser, Dakins Full Strength Solution, Di-Dak-Sol, Hysept, Dakins Quarter Strength Solution, Dakins Half Strength Solution, H-Chlor 6, H-Chlor Wound, H-Chlor 12

• It is used with a special imaging test of the thyroid gland.