Pretomanid Tablets and Quetiapine Fumarate Tablets

• 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: quetiapine
• Dosage Forms: tablet, extended release
• Other Brand Names: Seroquel, Seroquel XR

Quetiapine is an antipsychotic medicine that is used to treat schizophrenia in adults and children who are at least 13 years old.

Quetiapine is used to treat bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Quetiapine is also used together with antidepressant medications to treat major depressive disorder in adults.

Quetiapine may also be used for purposes not listed in this medication guide.