NUZYRA

批准信原文要点

These Prior Approval sNDAs provide for revisions to the prescribing information (PI) to remove the warning on mortality imbalance in patients with community-acquired bacterial pneumonia. Additionally, minor editorial revisions were made throughout the PI.

批准信原文要点

These supplemental new drug applications provide for revisions to the labeling for Nuzyra, consistent with our December 16, 2024, letter. This information pertains to the risk of fixed drug eruption.

批准信原文要点

These Prior Approval supplemental new drug applications provide for revisions to the prescribing information (PI), DOSAGE and ADMINISTRATION (2) section, Dosage in Adults with Community-Acquired Bacterial Pneumonia (CABP) (2.2) subsection, and CLINICAL PHARMACOLOGY (12) section, Pharmacokinetics (12.3) subsection, to add information on an oral loading and maintenance dose.

批准信原文要点

These Prior Approval supplemental new drug applications provide for addition of a new carton/container packaging presentation for a 6-count Professional Sample for NUZYRA tablets.

批准信原文要点

requesting an update to the WARNINGS AND PRECAUTIONS section (5), Clostridioides difficile-Associated Diarrhea subsection (5.5) and the Microbiology subsection (12.4) of the Prescribing Information (PI).

批准信原文要点

Manion: Please refer to your supplemental new drug applications (sNDA) dated April 28, 2020, received April 28, 2020, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for NDA NUMBER: 209816 SUPPLEMENT NUMBER: 008 PRODUCT NAME: NUZYRA (omadacycl…

批准信原文要点

These supplemental applications provide for changes to the section 14 CLINICAL STUDIES in subsections 14.1 Community-Acquired Bacterial Pneumonia and 14.2 Acute Bacterial Skin and Skin Structure Infections.

批准信原文要点

These Prior Approval supplemental new drug applications provide for changes to the Reconstitution and Dilution and Storage of the Diluted Infusion Solution subsections of the Preparation and Administration of NUZYRA for Injection Intravenous Solution (Section 2.5) to extend the in-use hold time from 48 hours to 7 days for omadacycline for injection in the infusion bags when stored at refrigerated conditions (2°C to 8°C).

批准信原文要点

These supplemental applications, submitted as “Changes Being Effected” supplements, provide for changes in the Storage of the Diluted Infusion Solution subsection of the Preparation and Administration of NUZYRA for Injection Intravenous Solution (Section 2.5) to reduce the in-use hold time from 24 hours to 12 hours for omadacycline diluted infusion solution when stored at room temperature.